AcneNCT01276535
Study of the Use of Low Level Laser Therapy to Reduce Acne
A study testing Erchonia MLS + Erchonia THL in people with Acne, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of acne blemishes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Erchonia MLS + Erchonia THL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- signed informed consent form.
- male or female.
- 18 to 40 years.
- area sought for acne reduction is the face.
- diagnosis of moderate or severe acne vulgaris, defined as grade 3-5 according to the grading criteria of acne severity given by Burton et al.
- Acne has been ongoing for at least 3 months prior to screening and must include inflammatory lesions.
Show all 15Show fewer
- female using hormonal birth control must have been on a stable dose for at least 3 months prior to screening.
- negative pregnancy test for female subjects, unless the female subject has been surgically sterilized.
- sexually active female subject who is not surgically sterile or 2 years post menopausal must agree to use approved contraception/birth control measure while on study
- PI (A normal healthy patient) or P2 (A patient with mild systemic disease) on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
- subject agrees to abstain from use of non-study treatments for acne while enrolled in the study.
- subject agrees to abstain from use of tanning beds/sunbathing while partaking in the study.
- subject agrees, and be able, to maintain regular medication schedule, as is medically feasible, during study participation.
- subject agrees to not change skin care regimen throughout study participation.
- subject is willing and able to comply with all requirements of the study protocol.
Who cannot join
- use of topical acne treatment within 15 days prior to start of study.
- use of oral acne treatment within 30 days prior to the start of study.
- use of oral isotretinoin or other systemic retinoids in the 12 months preceding the start of the study.
- use of systemic steroids within 30 days prior to the start of the study.
- pregnancy or currently nursing, or planning pregnancy during the course of the study
- participation in any clinical study involving an investigational product within 30 days of the start of the study
Show all 18Show fewer
- use of tanning beds or sunbathing in the 30 days prior to the start of the study.
- history of keloids or other photosensitive disorders or use of any photosensitizing medication.
- currently taking any medication that may alleviate or exacerbate acne.
- Porphyria or known allergies to porphyrins.
- current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- known malignancy or history of malignancy other than non-melanoma skin cancer
- human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- signs of bacterial, fungal or viral skin lesions that may interfere with assessment of acne vulgaris.
- known inherited or acquired coagulation defects.
- substance abuse (drug or alcohol) problem within the previous 3 years.
- developmental disability or cognitive impairment that may preclude study compliance.
- unlikely to comply with the study protocol and procedure administration protocol, or is considered unsuitable for participation in the study for any other reason in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Low-level Laser Therapy in Reducing Blemishes by Quantifying a Decrease in Signs of Blemishes, Both Non-inflammatory and Inflammatory
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of acne blemishes.
Read the detailed description
Acne is a chronic inflammatory disorder plaguing the sebaceous follicle, and debate still remains over what truly initiates lesion formation. Experts agree that an increase in androgen production plays a significant role in the onset of acne. Androgens promote the increase in size of sebaceous glands and stimulate sebum production. The simple act of sebaceous gland stimulation via androgens could ultimately promote the upregulation of pro-inflammatory cytokines like tumor necrosis factor-α (TNF-α) and interleukin (IL-1α) without propionibacteria even being present. The synthesis of IL-α and other pro-inflammatory cytokines including prostaglandins occurs via the inducible enzyme known as cyclooxygenase-2 (COX-2). Studies analyzing the pathogenesis of mucositis have identified COX-2 as an important contributor to the upregulation of pro-inflammatory cytokines and thus a major contributor to the progression of the disorder itself.
Recent evidence indicates that low-level laser therapy (LLLT) is able to significantly diminish the expression of COX-2, resulting in the reduction of inflammation. The ability to modulate the COX-2 pathways via LLLT is believed to inhibit the production of pro-inflammatory cytokines (i.e. TNF-α and IL- α) present in acne-prone skin.
- Conditions
- Acne
- Being tested
- Erchonia MLS + Erchonia THL
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia MLS + Erchonia THLDevice
The Erchonia® MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
The Erchonia THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
Administration of the MLS and the THL occur simultaneously over the 6-week administration phase.
The intent is to evaluate the effectiveness of Erchonia MLS \& Erchonia THL when administered together, and not to compare Erchonia MLS vs. Erchonia THL
| Study group | Role | What they receive |
|---|---|---|
| Erchonia MLS + Erchonia THL | Experimental | The Erchonia® MLS contains 5 independent diodes: 4 each emitting 17 milliwatt (mW) 635 nanometers (nm) of red laser light and the fifth diode emitting 17 mW, 405 nm of blue laser light.
The Erchonia THL is a single diode pulsed laser that emits 4.9 milliwatts (mW) of red 635 nanometer (nm) light. Receives: Device: Erchonia MLS + Erchonia THL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade on the Burton et al. Acne Severity Grade Scale
The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.
Measured: baseline and 6 weeks
Secondary outcomes (2)
Change From Baseline in Inflammatory Lesion Count at 6 Weeks
The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.
Measured: Baseline and 6 weeks
Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks
The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
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.
- Other trials for AcneStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory A Nikolaidis, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276535
- Sponsor's protocol ID
- ECACNEP1
- Status last verified
- Nov 2015
- First submitted
- 11 Jan 2011
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Low-level Laser Therapy in Reducing Blemishes by Quantifying a Decrease in Signs of Blemishes, Both Non-inflammatory and Inflammatory
- ClinicalTrials.gov ID
- NCT01276535
- Acronym / sponsor ID
- ECACNEP1
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of acne blemishes.
Detailed description
Acne is a chronic inflammatory disorder plaguing the sebaceous follicle, and debate still remains over what truly initiates lesion formation. Experts agree that an increase in androgen production plays a significant role in the onset of acne. Androgens promote the increase in size of sebaceous glands and stimulate sebum production. The simple act of sebaceous gland stimulation via androgens could ultimately promote the upregulation of pro-inflammatory cytokines like tumor necrosis factor-α (TNF-α) and interleukin (IL-1α) without propionibacteria even being present. The synthesis of IL-α and other pro-inflammatory cytokines including prostaglandins occurs via the inducible enzyme known as cyclooxygenase-2 (COX-2). Studies analyzing the pathogenesis of mucositis have identified COX-2 as an important contributor to the upregulation of pro-inflammatory cytokines and thus a major contributor to the progression of the disorder itself.
Recent evidence indicates that low-level laser therapy (LLLT) is able to significantly diminish the expression of COX-2, resulting in the reduction of inflammation. The ability to modulate the COX-2 pathways via LLLT is believed to inhibit the production of pro-inflammatory cytokines (i.e. TNF-α and IL- α) present in acne-prone skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia MLS + Erchonia THL | Experimental | Device: Erchonia MLS + Erchonia THLThe Erchonia® MLS contains 5 independent diodes: 4 each emitting 17 milliwatt (mW) 635 nanometers (nm) of red laser light and the fifth diode emitting 17 mW, 405 nm of blue laser light. The Erchonia THL is a single diode pulsed laser that emits 4.9 milliwatts (mW) of red 635 nanometer (nm) light. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- signed informed consent form.
- male or female.
- 18 to 40 years.
- area sought for acne reduction is the face.
- diagnosis of moderate or severe acne vulgaris, defined as grade 3-5 according to the grading criteria of acne severity given by Burton et al.
Key exclusion criteria (18 listed)
- use of topical acne treatment within 15 days prior to start of study.
- use of oral acne treatment within 30 days prior to the start of study.
- use of oral isotretinoin or other systemic retinoids in the 12 months preceding the start of the study.
- use of systemic steroids within 30 days prior to the start of the study.
- pregnancy or currently nursing, or planning pregnancy during the course of the study
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 |
|---|---|---|
| Erchonia MLS + Erchonia THLThe Erchonia® MLS is administered weekly for 6 continuous weeks at the test site by the study investigator. The Erchonia THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject. Administration of the MLS and the THL occur simultaneously over the 6-week administration phase. The intent is to evaluate the effectiveness of Erchonia MLS \& Erchonia THL when administered together, and not to compare Erchonia MLS vs. Erchonia THL | Device | Erchonia MLS + Erchonia THL |
Primary outcome
Grade on the Burton et al. Acne Severity Grade Scale
Time frame: baseline and 6 weeks
The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.
2 secondary outcomes
Change From Baseline in Inflammatory Lesion Count at 6 Weeks
Time frame: Baseline and 6 weeks
Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Gregory A Nikolaidis, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia MLS + Erchonia THL in people with Acne, run by Erchonia Corporation at 1 site 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 15 inclusion and 18 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: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 11 Dec 2015). 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?
Grade on the Burton et al. Acne Severity Grade Scale (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2015.