Acne Scarring in Skin of Color: Laser vs Microneedling

Boston University

Status: Withdrawn

Conditions: Acne Vulgaris; Scar

Treatments: Device: Fractional non-ablative 1,540nm laser; Device: Microneedling

Study type: Interventional

Funder types: Other

Identifiers

NCT03395678

H-37256

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Microneedling

Experimental group

Description:

Participants in this arm will receive 5 treatments of microneedling.

Treatment:

Device: Microneedling

Fractional non-ablative 1,540nm laser

Active Comparator group

Description:

Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.

Treatment:

Device: Fractional non-ablative 1,540nm laser