Acne Scarring in Skin of Color: Laser vs Microneedling

Not Applicable

Withdrawn

• Conditions: Acne Vulgaris; Scar
• Interventions: Device: Microneedling; Device: Fractional non-ablative 1,540nm laser

• Registration Number: NCT03395678
• Lead Sponsor: Boston University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Status Verified: 2019-11
• Study Start: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedling	Microneedling	Participants in this arm will receive 5 treatments of microneedling.
Fractional non-ablative 1,540nm laser	Fractional non-ablative 1,540nm laser	Participants in this arm will receive 5 treatments of fractional non-ablative1,540nm laser.

Primary Outcome Measures

Name	Time	Method
Change in the Goodman and Baron score	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.

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	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	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States