Acne Scarring in Skin of Color: Laser vs Microneedling

• ClinicalTrials.gov Identifier: NCT03395678
• Recruitment Status: Withdrawn
• First Posted: January 10, 2018
• Last Update Posted: November 13, 2019
• Sponsor: Boston University
• Information provided by (Responsible Party): Boston University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris; Scar	Device: Microneedling; Device: Fractional non-ablative 1,540nm laser	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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: November 2019
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Microneedling; Participants in this arm will receive 5 treatments of microneedling.	Device: 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

Investigators

• Principal Investigator: Hye Jin Chung, MD, MMS; Boston University Department of Dermatology

More Information

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT03395678
• Other Study ID Numbers: H-37256
• First Posted: January 10, 2018
• Last Update Posted: November 13, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston University:

Microneedling; Nonablative fractional lasers; Fitzpatrick skin types III-V; Arophic acne scarring

Additional relevant MeSH terms:

Acne Vulgaris; Cicatrix; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes