Acne Scarring in Skin of Color: Laser vs Microneedling

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03395678
• Other study ID #: H-37256
• Status: Withdrawn
• Phase: N/A
• Start date: November 2019
• Est. completion date: December 2020

Study information

• Verified date: November 2019
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris
• Cicatrix
• Scar

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Goodman and Baron score	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.	Before treatment starts and 3 months after the last/5th treatment
Secondary	Treatment satisfaction	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.	3 months after the last/5th treatment
Secondary	Impact of skin disease on the quality of life	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.	3 months after the last/5th treatment