Acne VulgarisNCT02431494
Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris
A study testing Blue light phototherapy, Microcurrent therapy and Combination of BLP and Microcurrent in people with Acne Vulgaris and Acne, run by Nova Southeastern University at 2 sites in United States.
Trial summary
Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in visible lesions that can be quite disfiguring. Consequently, individuals with acne often suffer from a wide range of psychological manifestations. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Acne Vulgaris, Acne
- What is being tested?
- Blue light phototherapy, Microcurrent therapy and Combination of BLP and Microcurrent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2014to 12 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have mild to moderate facial acne
- Have Fitzpatrick skin type II-V
- Be able to understand written and/or spoken English
- Be able to provide written informed consent.
Who cannot join
- Have been treated with oral retinoids in the past 6 months
- Have been treated with oral antibiotic within the last 30 days
- Have received topical acne treatment (i.e. retinoids, antibiotics and anti-inflammatory agents or chemical peeling) within the last 30 days
- Pregnant or lactating
- Have history of photo-sensitive dermatitis
- Have previously received light therapy
- Taking oral contraceptive pills (OCP)
- Have pacemaker
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NSU COM Division of Dermatology, General, Cosmetic Dermatology and Cutaneous Surgery
Fort Lauderdale, Florida, 33328
Hollywood Dermatology
Hollywood, Florida, 33021
About this study
Official title: Safety and Preliminary Efficacy of Combination Blue Light Phototherapy and Microcurrent Therapy for the Treatment of Acne Vulgaris
Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in visible lesions that can be quite disfiguring. Consequently, individuals with acne often suffer from a wide range of psychological manifestations. Although there is consensus that combination therapy is most effective in treating acne, researchers are constantly striving to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has successfully been used to promote wound healing and has been routinely used in aesthetics. Use of MCT alone or in combination with current successful treatment such as blue light phototherapy (BLP), may hold promise for acne treatment. The investigators propose to conduct a small randomized control trial to determine the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris. The investigators will recruit up to 60 males and females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination therapy (BLP and MCT). The investigators will assess physiological parameters (number of acne lesions, amount of sebum produced, degree of acne severity) and psychosocial factors (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem). Participants will complete a baseline assessment prior to initiating treatment and a follow-up assessment at 4 weeks post termination of treatment. The investigators will conduct intermediary assessments at weeks 3 and 5 and 1 week post termination of the treatment. The investigators will use measures of central tendency to describe the sample and repeated measures analysis of variance to compute the main and interaction effects.
Read the detailed description
Overview: The goal of this study is to conduct a small randomized control trial (RCT) to test the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris. The investigators will also explore the effects of the treatments on psychosocial factors (Dermatology Life Quality Index (DLQI), social anxiety, depressive symptomatology, and self-esteem). The RCT will have 3 arms: 1) FDA approved treatment: blue light phototherapy (BLP); 2) Microcurrent therapy (MCT); and 3) combination therapy (BLP + MCT). The main outcomes will be: 1) number of acne lesions; 2) amount of sebum produced, 3) degree of acne severity; and 4) improvement in dermatologic quality of life. The specific aims of the study are:
Aim 1: To explore the use of MCT to improve blood flow and lymphatic drainage and promote tissue repair in patients with acne vulgaris.
Aim 2: To examine the safety and preliminary efficacy of enhancing traditional blue light therapy treatment with microcurrent therapy (BLP + MCT) to promote faster healing in patients with acne vulgaris.
Aim 3: To determine if combination therapy is a more effective (fewer number of acne lesions, decreased amount of sebum produced, lesser degree of acne severity and greater improvement in dermatologic quality of life) for acne than either type of monotherapy.
Aim 4: To explore the effects of the three modalities on psychosocial factors (social anxiety, depressive symptomatology, and self-esteem).
The investigators will recruit up to 60 males and females and randomly assign them to one of 3 treatment arms (blue light phototherapy (BLP); microcurrent therapy (MCT); and combination therapy (BLP and MCT). All participants will complete a baseline assessment prior to initiating treatment one follow-up assessment at 4 weeks post termination of treatment. During the treatment phase, the investigators will conduct intermediary assessments to track the progression of the treatment over time at weeks 3 and 5 as well as 1 week post the termination of the treatment (week 6). The investigators will conduct both physiological and psychosocial assessments; the content of the intermediary assessment will be much less than the other 3 assessments to reduce participant data. The most comprehensive assessments will be conducted at baseline and one follow-up points and will consist of all of the physiological and psychosocial factors as well as demographic factors that will be collected exclusively at the baseline assessment. At the intermediary assessments, the investigators will collect the number of acne lesions, amount of sebum produced and dermatologic quality of life. Psychosocial data will be collected via computer-assisted self-interviews (CASI). Physiological data will be entered into the computer program by research staff.
Procedures for collecting psychosocial data: All assessments will be conducted using computer-assisted self-interviews (CASI). Participants will be assigned a unique study identification number (ID) that will be used to track data. Computer-assisted self-interviews are more effective than other tools for measuring sensitive and socially stigmatized behaviors. This mode of data collection eliminates interviewer bias, standardizes questionnaire administration, and reduces skip pattern errors. Using CASI, the participant responds to the questions using the computer keyboard or mouse. Selection of CASI for data collection decreases costs and error of entry, cleaning data, and publication lag, as well as enhances interviewer efficiency. The laptop computers the investigators use for data collection have been set up with two different log-in screens, one for participants and one for an administrator. The screen used by participants only contains the icon to access the CASI system. No other files appear or are available on this screen. The investigators access the CASI for participants by clicking the icon and filling in the assigned participant ID number (not participant name) completing all set up procedures. The investigator then provides a brief training on using the laptop and completing the CASI. As part of this training, the participant will complete a brief set of practice questions illustrative of the type of questions and the responses contained in the assessment. The investigator remains with the participant during the practice session to answer questions or to provide additional instructions. Participants will be encouraged to seek assistance, if needed, as they complete the interview. At this point, the interview starts and the participant completes the interview on their own. Once the participant completes the interview, he/she comes upon a screen instructing him/her to contact the investigators so that the file may be saved correctly.
Procedures for collecting physiological data: The investigators will conduct visual inspection of the affected areas and systematically count the number of acne lesions present on the face. At baseline and the follow-up assessment the investigators will also take high quality digital photographs of the affected areas that will be used to compute the degree of acne severity. The photographs will be identified exclusively by study ID and will be kept in a password protected file in a secure NSU computer. The Sebumeter® SM 815 sebum meter will be used to estimate the amount of sebum produced. The investigators will bring the mat tape of the meter in contact with the affected areas. This instrument uses a non-invasive probe placed on the affected area and the instrument then calculates the amount of sebum produced.
- Conditions
- Acne Vulgaris, Acne
- Being tested
- Blue light phototherapy, Microcurrent therapy, Combination of BLP and Microcurrent
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light phototherapyDevice
Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes.
Microcurrent therapyDevice
Microcurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. The duration of each session will be approximately 45 minutes.
Combination of BLP and MicrocurrentDevice
Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.
| Study group | Role | What they receive |
|---|---|---|
| BLP arm (Blue Light Phototherapy) | Active comparator | In this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. Receives: Device: Blue light phototherapy |
| MCT arm (Microcurrent Therapy) | Active comparator | In this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. Receives: Device: Microcurrent therapy |
| Combination of BLP and Microcurrent | Active comparator | In this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes. Receives: Device: Combination of BLP and Microcurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Acne Lesions Over the Course of 9 Weeks
The investigators will conduct a systematic count of acne lesions (papules and pustules) present in all of the affected areas of the face.
Measured: Weeks 1,3,5,6,9
Change in the Amount of Sebum Produced Over the Course of 9 Weeks
The investigators will use the Sebumeter® SM 815 manufactured by CK Electronic to estimate the amount of sebum. The measurement is based on grease spot photometry. The mat tape of the Sebumeter® SM 815 is brought into contact with facial skin. It becomes transparent in relation to the sebum on the surface of the measurement area. Then the tape is inserted into the aperture of the device and the transparency is measured by a photocell. The light transmission represents the sebum content.
Measured: Weeks 1,3,5,6,9
Change in Acne Severity Over the Course of 9 Weeks
The investigators will use the acne counts and the digital photographs of the affected areas to compute the acne severity level following the procedures established by Hayashi et al. (2008). The investigators will not print the digital photographs. The investigators will visually inspect the digital photographs and assign a preliminary severity score to each half of the face using the following classification guide: 0-5 papules and/pustules for mild acne; 6-20 for moderate acne, 21-50 for severe acne; and more than 50 for very severe. The investigators will examine each half of the face separately. The most severe classification obtained for either side of the face will be the assigned severity score.
Measured: Weeks 1 and 9
Change in Dermatologic Quality of Life Over the Course of 9 Weeks
The investigators will use the Dermatology Life Quality Index (DLQI) developed by A. Y. Finlay and G. K. Khan (1992), one of the most widely used, dermatologic specific quality of life measures in the published literature to assess quality of life. The DLQI consists of 10 Likert type items; 9 of these items have 4 response categories scored from 0 to 3 with "very much" being "3" to "not at all" being "0". Item 7 "Over the last week, has participant's skin prevented participant from working or studying" uses dichotomous responses; where "yes" is scored as a "3" and a "no" requires answering an additional sub-question, "Over the past week how much has participant's skin been a problem at work or studying". Responses for this sub-question range from "a lot" coded a "2", to "not at all" coded a "0." The DLQI is calculated by summing the response to each question; the maximum score is "30" and the minimum score is "0". The higher the score, the lower the dermatologic quality of life.
Measured: Weeks 1,3,5,6,9
Secondary outcomes (3)
Change in Social Anxiety Score Over the Course of 9 Weeks
Symptoms of social anxiety will be assessed using the Liebowitz Social Anxiety Scale (Liebowitz, 1987), one of the most widely used scales to measure social anxiety. It consists of 24 items designed to assess fear and avoidance in different situations that are likely to produce social anxiety such as going to a party or speaking in public. For each situation, participants are first asked to state how fearful or anxious they feel in that situation using a Likert scale that ranges from "none" (0) to "severe" (3). Then they are asked to state how often they avoid that same situation using a Likert scale that ranges from "never" (0) to "usually" (3). Responses are summed to create an overall anxiety score.
Measured: Weeks 1 and 9
Change in Depressive Symptomatology Score Over the Course of 9 Weeks
The investigators will assess depressive symptomatology using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983), one of the most widely used screening tools to identify symptoms of depression, anxiety and emotional distress amongst patients being treated for a variety of clinical problems. It consists of 14 items, 7 of which assess generalized symptoms of anxiety and the remaining 7 assess depressive symptomatology. Although the specific wording of the item responses vary in accordance to the item, all responses are coded using a Likert format ranging from "0" to "3" where the most positive response is coded a "0" and the most negative response a "3". The maximum score for each subscale is 21; higher scores are reflective of more symptoms of anxiety or depression.
Measured: Weeks 1 and 9
Change of Self-esteem Score Over the Course of 9 Weeks
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale, one of the most widely-used self-esteem measures in social science research. It consists of ten items designed to assess respondent's self-satisfaction, self-respect and other general feelings about himself/herself. The response format is a four point Likert scale ranging from "strongly agree" to "strongly disagree". For items 1, 2, 4, 6, 7: Strongly Agree=3, Agree=2, Disagree=1, and Strongly Disagree=0. For items 3, 5, 8, 9, 10: Strongly Agree=0, Agree=1, Disagree=2, and Strongly Disagree=3. The scale ranges from 0-30, higher scores indicating higher self-esteem.
Measured: Weeks 1 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study start30 Oct 2014
- Primary completion12 May 2017
- Study completion12 May 2017
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey Arutyunyan, M.S., Principal investigator, Nova Southeastern University College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431494
- Sponsor's protocol ID
- 08291420Exp
- Status last verified
- Feb 2020
- First submitted
- 21 Apr 2015
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Uhlenhake E, Yentzer BA, Feldman SR. Acne vulgaris and depression: a retrospective examination. J Cosmet Dermatol. 2010 Mar;9(1):59-63. doi: 10.1111/j.1473-2165.2010.00478.x.
PubMed 20367674Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, Shalita AR, Thiboutot D; Global Alliance to Improve Outcomes in Acne. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003 Jul;49(1 Suppl):S1-37. doi: 10.1067/mjd.2003.618. No abstract available.
PubMed 12833004Cunliffe WJ. The sebaceous gland and acne--40 years on. Dermatology. 1998;196(1):9-15. doi: 10.1159/000017859. No abstract available.
PubMed 9557218Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.
PubMed 9892952Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
PubMed 12589953Cheng N, Van Hoof H, Bockx E, Hoogmartens MJ, Mulier JC, De Dijcker FJ, Sansen WM, De Loecker W. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin Orthop Relat Res. 1982 Nov-Dec;(171):264-72.
PubMed 7140077Bach S, Bilgrav K, Gottrup F, Jorgensen TE. The effect of electrical current on healing skin incision. An experimental study. Eur J Surg. 1991 Mar;157(3):171-4.
PubMed 1678624Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
PubMed 3893385
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Combination Blue Light Phototherapy and Microcurrent Therapy for the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02431494
- Acronym / sponsor ID
- 08291420Exp
- Conditions
- Acne Vulgaris, Acne
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 12 May 2017 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a multifactorial, highly prevalent dermatologic condition that results in visible lesions that can be quite disfiguring. Consequently, individuals with acne often suffer from a wide range of psychological manifestations. Although there is consensus that combination therapy is most effective in treating acne, researchers are constantly striving to develop new treatment. Microcurrent therapy (MCT) is a non-invasive modality that has successfully been used to promote wound healing and has been routinely used in aesthetics. Use of MCT alone or in combination with current successful treatment such as blue light phototherapy (BLP), may hold promise for acne treatment. The investigators propose to conduct a small randomized control trial to determine the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris. The investigators will recruit up to 60 males and females and randomly assign them to one of 3 arms: 1) BLP; 2) MCT; and combination therapy (BLP and MCT). The investigators will assess physiological parameters (number of acne lesions, amount of sebum produced, degree of acne severity) and psychosocial factors (dermatologic quality of life, social anxiety, depressive symptomatology, self-esteem). Participants will complete a baseline assessment prior to initiating treatment and a follow-up assessment at 4 weeks post termination of treatment. The investigators will conduct intermediary assessments at weeks 3 and 5 and 1 week post termination of the treatment. The investigators will use measures of central tendency to describe the sample and repeated measures analysis of variance to compute the main and interaction effects.
Detailed description
Overview: The goal of this study is to conduct a small randomized control trial (RCT) to test the safety and preliminary efficacy of a novel combination therapy to treat acne vulgaris. The investigators will also explore the effects of the treatments on psychosocial factors (Dermatology Life Quality Index (DLQI), social anxiety, depressive symptomatology, and self-esteem). The RCT will have 3 arms: 1) FDA approved treatment: blue light phototherapy (BLP); 2) Microcurrent therapy (MCT); and 3) combination therapy (BLP + MCT). The main outcomes will be: 1) number of acne lesions; 2) amount of sebum produced, 3) degree of acne severity; and 4) improvement in dermatologic quality of life. The specific aims of the study are:
Aim 1: To explore the use of MCT to improve blood flow and lymphatic drainage and promote tissue repair in patients with acne vulgaris.
Aim 2: To examine the safety and preliminary efficacy of enhancing traditional blue light therapy treatment with microcurrent therapy (BLP + MCT) to promote faster healing in patients with acne vulgaris.
Aim 3: To determine if combination therapy is a more effective (fewer number of acne lesions, decreased amount of sebum produced, lesser degree of acne severity and greater improvement in dermatologic quality of life) for acne than either type of monotherapy.
Aim 4: To explore the effects of the three modalities on psychosocial factors (social anxiety, depressive symptomatology, and self-esteem).
The investigators will recruit up to 60 males and females and randomly assign them to one of 3 treatment arms (blue light phototherapy (BLP); microcurrent therapy (MCT); and combination therapy (BLP and MCT). All participants will complete a baseline assessment prior to initiating treatment one follow-up assessment at 4 weeks post termination of treatment. During the treatment phase, the investigators will conduct intermediary assessments to track the progression of the treatment over time at weeks 3 and 5 as well as 1 week post the termination of the treatment (week 6). The investigators will conduct both physiological and psychosocial assessments; the content of the intermediary assessment will be much less than the other 3 assessments to reduce participant data. The most comprehensive assessments will be conducted at baseline and one follow-up points and will consist of all of the physiological and psychosocial factors as well as demographic factors that will be collected exclusively at the baseline assessment. At the intermediary assessments, the investigators will collect the number of acne lesions, amount of sebum produced and dermatologic quality of life. Psychosocial data will be collected via computer-assisted self-interviews (CASI). Physiological data will be entered into the computer program by research staff.
Procedures for collecting psychosocial data: All assessments will be conducted using computer-assisted self-interviews (CASI). Participants will be assigned a unique study identification number (ID) that will be used to track data. Computer-assisted self-interviews are more effective than other tools for measuring sensitive and socially stigmatized behaviors. This mode of data collection eliminates interviewer bias, standardizes questionnaire administration, and reduces skip pattern errors. Using CASI, the participant responds to the questions using the computer keyboard or mouse. Selection of CASI for data collection decreases costs and error of entry, cleaning data, and publication lag, as well as enhances interviewer efficiency. The laptop computers the investigators use for data collection have been set up with two different log-in screens, one for participants and one for an administrator. The screen used by participants only contains the icon to access the CASI system. No other files appear or are available on this screen. The investigators access the CASI for participants by clicking the icon and filling in the assigned participant ID number (not participant name) completing all set up procedures. The investigator then provides a brief training on using the laptop and completing the CASI. As part of this training, the participant will complete a brief set of practice questions illustrative of the type of questions and the responses contained in the assessment. The investigator remains with the participant during the practice session to answer questions or to provide additional instructions. Participants will be encouraged to seek assistance, if needed, as they complete the interview. At this point, the interview starts and the participant completes the interview on their own. Once the participant completes the interview, he/she comes upon a screen instructing him/her to contact the investigators so that the file may be saved correctly.
Procedures for collecting physiological data: The investigators will conduct visual inspection of the affected areas and systematically count the number of acne lesions present on the face. At baseline and the follow-up assessment the investigators will also take high quality digital photographs of the affected areas that will be used to compute the degree of acne severity. The photographs will be identified exclusively by study ID and will be kept in a password protected file in a secure NSU computer. The Sebumeter® SM 815 sebum meter will be used to estimate the amount of sebum produced. The investigators will bring the mat tape of the meter in contact with the affected areas. This instrument uses a non-invasive probe placed on the affected area and the instrument then calculates the amount of sebum produced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLP arm (Blue Light Phototherapy) | Active comparator | Device: Blue light phototherapyIn this arm participants will receive 5 BLP sessions at 1 week intervals. The duration of each session will be approximately 20 minutes. At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. |
| MCT arm (Microcurrent Therapy) | Active comparator | Device: Microcurrent therapyIn this arm participants will receive 5 MCT sessions 1 week intervals using MCT machine. The duration of each session will be approximately 45 minutes. The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. |
| Combination of BLP and Microcurrent | Active comparator | Device: Combination of BLP and MicrocurrentIn this arm participants will receive 5 BLP and 5 MCT sessions at 1 week intervals. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have mild to moderate facial acne
- Have Fitzpatrick skin type II-V
- Be able to understand written and/or spoken English
- Be able to provide written informed consent.
Key exclusion criteria (8 listed)
- Have been treated with oral retinoids in the past 6 months
- Have been treated with oral antibiotic within the last 30 days
- Have received topical acne treatment (i.e. retinoids, antibiotics and anti-inflammatory agents or chemical peeling) within the last 30 days
- Pregnant or lactating
- Have history of photo-sensitive dermatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light phototherapyBlue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes. | Device | BLP arm (Blue Light Phototherapy) |
| Microcurrent therapyMicrocurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. The duration of each session will be approximately 45 minutes. | Device | MCT arm (Microcurrent Therapy) |
| Combination of BLP and MicrocurrentSame devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes. | Device | Combination of BLP and Microcurrent |
Primary outcome
Change in Number of Acne Lesions Over the Course of 9 Weeks
Time frame: Weeks 1,3,5,6,9
The investigators will conduct a systematic count of acne lesions (papules and pustules) present in all of the affected areas of the face.
Change in the Amount of Sebum Produced Over the Course of 9 Weeks
Time frame: Weeks 1,3,5,6,9
The investigators will use the Sebumeter® SM 815 manufactured by CK Electronic to estimate the amount of sebum. The measurement is based on grease spot photometry. The mat tape of the Sebumeter® SM 815 is brought into contact with facial skin. It becomes transparent in relation to the sebum on the surface of the measurement area. Then the tape is inserted into the aperture of the device and the transparency is measured by a photocell. The light transmission represents the sebum content.
Change in Acne Severity Over the Course of 9 Weeks
Time frame: Weeks 1 and 9
The investigators will use the acne counts and the digital photographs of the affected areas to compute the acne severity level following the procedures established by Hayashi et al. (2008). The investigators will not print the digital photographs. The investigators will visually inspect the digital photographs and assign a preliminary severity score to each half of the face using the following classification guide: 0-5 papules and/pustules for mild acne; 6-20 for moderate acne, 21-50 for severe acne; and more than 50 for very severe. The investigators will examine each half of the face separately. The most severe classification obtained for either side of the face will be the assigned severity score.
Change in Dermatologic Quality of Life Over the Course of 9 Weeks
Time frame: Weeks 1,3,5,6,9
The investigators will use the Dermatology Life Quality Index (DLQI) developed by A. Y. Finlay and G. K. Khan (1992), one of the most widely used, dermatologic specific quality of life measures in the published literature to assess quality of life. The DLQI consists of 10 Likert type items; 9 of these items have 4 response categories scored from 0 to 3 with "very much" being "3" to "not at all" being "0". Item 7 "Over the last week, has participant's skin prevented participant from working or studying" uses dichotomous responses; where "yes" is scored as a "3" and a "no" requires answering an additional sub-question, "Over the past week how much has participant's skin been a problem at work or studying". Responses for this sub-question range from "a lot" coded a "2", to "not at all" coded a "0." The DLQI is calculated by summing the response to each question; the maximum score is "30" and the minimum score is "0". The higher the score, the lower the dermatologic quality of life.
3 secondary outcomes
Change in Social Anxiety Score Over the Course of 9 Weeks
Time frame: Weeks 1 and 9
Change in Depressive Symptomatology Score Over the Course of 9 Weeks
Time frame: Weeks 1 and 9
Change of Self-esteem Score Over the Course of 9 Weeks
Time frame: Weeks 1 and 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20367674Uhlenhake E, Yentzer BA, Feldman SR. Acne vulgaris and depression: a retrospective examination. J Cosmet Dermatol. 2010 Mar;9(1):59-63. doi: 10.1111/j.1473-2165.2010.00478.x.
- Background: PubMed 12833004Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, Shalita AR, Thiboutot D; Global Alliance to Improve Outcomes in Acne. Management of acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 2003 Jul;49(1 Suppl):S1-37. doi: 10.1067/mjd.2003.618. No abstract available.
- Background: PubMed 9557218Cunliffe WJ. The sebaceous gland and acne--40 years on. Dermatology. 1998;196(1):9-15. doi: 10.1159/000017859. No abstract available.
- Background: PubMed 9892952Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x.
- Background: PubMed 12589953Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24. doi: 10.1111/j.1574-695X.2003.tb00644.x.
- Background: PubMed 7140077Cheng N, Van Hoof H, Bockx E, Hoogmartens MJ, Mulier JC, De Dijcker FJ, Sansen WM, De Loecker W. The effects of electric currents on ATP generation, protein synthesis, and membrane transport of rat skin. Clin Orthop Relat Res. 1982 Nov-Dec;(171):264-72.
- Background: PubMed 1678624Bach S, Bilgrav K, Gottrup F, Jorgensen TE. The effect of electrical current on healing skin incision. An experimental study. Eur J Surg. 1991 Mar;157(3):171-4.
- Background: PubMed 3893385Carley PJ, Wainapel SF. Electrotherapy for acceleration of wound healing: low intensity direct current. Arch Phys Med Rehabil. 1985 Jul;66(7):443-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Arutyunyan, M.S. principal investigator
Nova Southeastern University College of Osteopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light phototherapy, Microcurrent therapy and Combination of BLP and Microcurrent in people with Acne Vulgaris and Acne, run by Nova Southeastern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Acne Lesions Over the Course of 9 Weeks (time frame: Weeks 1,3,5,6,9). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431494, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.