Clinical trial NCT03395678: Acne Scarring in Skin of Color: Laser vs Microneedling
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Scar
Keywords: Microneedling
Nonablative fractional lasers
Fitzpatrick skin types III-V
Arophic acne scarring
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in the Goodman and Baron score
timeFrame: Before treatment starts and 3 months after the last/5th treatment
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: 3 months after the last/5th treatment
measure: Impact of skin disease on the quality of life
timeFrame: 3 months after the last/5th treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University Department of Dermatology
name: Hye Jin Chung, MD, MMS
role: PRINCIPAL_INVESTIGATOR
References: