Acne VulgarisNCT03395678
Acne Scarring in Skin of Color: Laser vs Microneedling
A study testing Microneedling and Fractional non-ablative 1,540nm laser in people with Acne Vulgaris and Scar, run by Boston University at 1 site in United States.
Trial summary
Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris, Scar
- What is being tested?
- Microneedling and Fractional non-ablative 1,540nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
- Individuals (men and women) aged 18 and older
- Patients must have atrophic facial acne scarring on the face and desire treatment to improve appearance of acne scarring
- Patients must have Fitzpatrick skin type III-VI
- Patients must be willing to receive five acne scarring treatments at monthly intervals with one follow-up visit to assess for efficacy and adverse effects
- Subjects must speak either English, Chinese, or Spanish.
Who cannot join
- Subjects who are unable or unwilling to give informed consent.
- Personal history of photosensitivity or photosensitive diseases.
- Pregnancy or breast-feeding.
- Facial surgical or laser treatment in the last 3 months.
- Patients with any active skin infection in the treatment area.
- Coagulopathies or anticoagulant therapy.
- Personal history or presence of hypertrophic scars or keloids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Though many treatments for acne scarring exist including ablative and nonablative lasers, subcision, and peels, none is without risk of adverse effects of pain, post-procedure redness or pigmentary changes. There have been no randomized studies directly comparing the effectiveness and safety profiles of microneedling (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of atrophic acne scarring in skin of color. This clinical trial aims to determine which treatment modality -- microneedling or nonablative fractional laser -- is safer and more efficacious in the treatment of acne scarring in patients with skin of color.
- Conditions
- Acne Vulgaris, Scar
- Being tested
- Microneedling, Fractional non-ablative 1,540nm laser
- Keywords
- Microneedling, Nonablative fractional lasers, Fitzpatrick skin types III-V, Arophic acne scarring
- Medical subject headings
- Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingDevice
Also called DermaPen 3MD
The exact microneedling settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
Fractional non-ablative 1,540nm laserDevice
Also called Palomar StarLux
The exact laser settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | Participants in this arm will receive 5 treatments of microneedling. Receives: Device: Microneedling |
| Fractional non-ablative 1,540nm laser | Active comparator | Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser. Receives: Device: Fractional non-ablative 1,540nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Goodman and Baron score
The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable.
Measured: Before treatment starts and 3 months after the last/5th treatment
Secondary outcomes (2)
Treatment satisfaction
A questionnaire with questions about participant satisfaction with the treatment, perceived improvement, and perceived adverse effects will be administered at the last visit, 3 months after the treatment is complete. Responses will be compared between the two treatment arms.
Measured: 3 months after the last/5th treatment
Impact of skin disease on the quality of life
Impact of skin disease on the quality of life will be assessed using the Dermatology life Quality Index (DLQI) which is a ten-question questionnaire with responses options of: Very much=3, A lot=2, A little=1, Not at all=0, or Not relevant=0. Range of scores are from 0 to 30 and interpreted as: 0 - 1= no effect at all on patient's life, 2 - 5= small effect on patient's life, 6 - 10= moderate effect on patient's life, 11 - 20= very large effect on patient's life, and 21 - 30= extremely large effect on patient's life. Responses will be compared between the two treatment arms.
Measured: 3 months after the last/5th treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study startNov 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Sample size can not be obtained at this site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hye Jin Chung, MD, MMS, Principal investigator, Boston University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395678
- Sponsor's protocol ID
- H-37256
- Status last verified
- Nov 2019
- First submitted
- 4 Jan 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fractionated 1,540nm Nonablative Laser and Microneedling in the Treatment of Atrophic Acne Scarring in Skin of Color: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03395678
- Acronym / sponsor ID
- H-37256
- Conditions
- Acne Vulgaris, Scar
- Keywords
- Microneedling, Nonablative fractional lasers, Fitzpatrick skin types III-V, Arophic acne scarring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sample size can not be obtained at this site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrophic acne scars are a common and important sequelae of acne that affect up to 43-55% of patients with acne. Scarring impacts quality of life with reports of diminished self-esteem and frustration/sadness; additionally, some individuals report that their appearance even interferes with their professional lives. Though many treatments for acne scarring exist including ablative and nonablative lasers, subcision, and peels, none is without risk of adverse effects of pain, post-procedure redness or pigmentary changes. There have been no randomized studies directly comparing the effectiveness and safety profiles of microneedling (Dermapen) to 1,540nm nonablative fractional lasers (Palomar StarLux) in the treatment of atrophic acne scarring in skin of color. This clinical trial aims to determine which treatment modality -- microneedling or nonablative fractional laser -- is safer and more efficacious in the treatment of acne scarring in patients with skin of color.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: MicroneedlingParticipants in this arm will receive 5 treatments of microneedling. |
| Fractional non-ablative 1,540nm laser | Active comparator | Device: Fractional non-ablative 1,540nm laserParticipants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients referred to dermatology clinic for any reason, or resident or attending dermatologists at Boston University.
- Individuals (men and women) aged 18 and older
- Patients must have atrophic facial acne scarring on the face and desire treatment to improve appearance of acne scarring
- Patients must have Fitzpatrick skin type III-VI
- Patients must be willing to receive five acne scarring treatments at monthly intervals with one follow-up visit to assess for efficacy and adverse effects
Key exclusion criteria (7 listed)
- Subjects who are unable or unwilling to give informed consent.
- Personal history of photosensitivity or photosensitive diseases.
- Pregnancy or breast-feeding.
- Facial surgical or laser treatment in the last 3 months.
- Patients with any active skin infection in the treatment area.
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 |
|---|---|---|
| MicroneedlingAlso: DermaPen 3MDThe exact microneedling settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart. | Device | Microneedling |
| Fractional non-ablative 1,540nm laserAlso: Palomar StarLuxThe exact laser settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart. | Device | Fractional non-ablative 1,540nm laser |
Primary outcome
Change in the Goodman and Baron score
Time frame: Before treatment starts and 3 months after the last/5th treatment
The Goodman and Baron score considers type of scar, number of scars, and severity of scarring and assigns a grade 1-4 with grade 1 representing mild, macular disease and grade 4 representing severe scarring that is obviously visible at social distances of 50cm, is not easily covered by makeup, and is not able to be flattened by manual stretching of the skin. Lower scores are favorable.
2 secondary outcomes
Treatment satisfaction
Time frame: 3 months after the last/5th treatment
Impact of skin disease on the quality of life
Time frame: 3 months after the last/5th treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- 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.
Hye Jin Chung, MD, MMS principal investigator
Boston University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling and Fractional non-ablative 1,540nm laser in people with Acne Vulgaris and Scar, run by Boston University 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 the Goodman and Baron score (time frame: Before treatment starts and 3 months after the last/5th treatment). 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 13 Nov 2019.