Acne Scarring in Skin of Color: Laser vs Microneedling
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Acne, Acne, Cosmetic, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | April 2019 |
| End Date: | March 2020 |
| Contact: | Hye Jin Chung, MD, MMS |
| Email: | HyeJin.Chung@bmc.org |
| Phone: | 617-638-7420 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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