Acne Scarring in Skin of Color: Laser vs Microneedling
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|ClinicalTrials.gov Identifier: NCT03395678|
Recruitment Status : Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Scar||Device: Microneedling Device: Fractional non-ablative 1,540nm laser||Not Applicable|
This is a randomized, prospective clinical trial of 30 healthy patients with Fitzpatrick skin phototypes III-V with atrophic acne scars on the face who desire treatment of their scars. Subjects with skin phototypes III - V are being studied because this population has been underrepresented in literature on treatment of acne scarring and also has been shown to have a higher incidence of adverse effects including post-inflammatory hyperpigmentation from established treatments for acne scarring such as ablative laser resurfacing. Each treatment group of 15 subjects will be composed of 5 patients each with skin type III, IV, and V.
Participants will have a total of 7 visits lasting between thirty minutes to one hour in duration. The first visit will be an assessment for inclusion in the study. Once consented participants will randomized to either the laser arm that will be treated with a 1,540nm fractional nonablative laser (Palomar StarLux) or the microneedling arm that will be treated with a microneedling device (Dermapen 3MD). The precise laser or microneedling settings will be tailored to each participant. After enrollment and prior to the first treatment session, participants in both groups will pretreat with adapalene 0.1% gel, hydroquinone 2% cream, and sunscreen to the face daily for 4 weeks prior to first treatment. This is an acceptable pre-treatment protocol in the treatment of acne scarring.
Participants will receive a series of 5 treatment sessions of either the laser or microneedling per randomization protocol at 4-6 week intervals. At each visit, participants will be asked about any adverse effects and also examined by either the PI or co-investigator. If any adverse effects are noted, subjects will have the option of either continuing or discontinuing their involvement in the study. Standardized high-resolution digital photographs of all patients will be taken at baseline (pre-treatment) and 3 months after the last treatment session. At that 3 months follow up participants will also be asked to complete a questionnaire about their treatment experiences and satisfaction with the outcome and the Dermatology Life Quality Index questionnaire. If the study reveals that one treatment modality is far superior to the other treatment, participants randomized to the inferior treatment modality will be offered the superior treatment at no cost.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||September 2020|
Participants in this arm will receive 5 treatments of microneedling.
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.
Other Name: DermaPen 3MD
Active Comparator: Fractional non-ablative 1,540nm laser
Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.
Device: Fractional non-ablative 1,540nm laser
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.
Other Name: Palomar StarLux
- 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.
- Treatment satisfaction [ Time Frame: 3 months after the last/5th treatment ]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.
- Impact of skin disease on the quality of life [ Time Frame: 3 months after the last/5th treatment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395678
|Contact: Hye Jin Chung, MD, MMS||617-638-7420||HyeJin.Chung@bmc.org|
|United States, Massachusetts|
|Boston Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Hye Jin Chung, MD MMS 617-638-7420 HyeJin.Chung@bmc.org|
|Principal Investigator:||Hye Jin Chung, MD, MMS||Boston University Department of Dermatology|