Acne Scarring in Skin of Color: Laser vs Microneedling

NCT ID: NCT03395678

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Acne Vulgaris Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Microneedling

Participants in this arm will receive 5 treatments of microneedling.

Group Type EXPERIMENTAL

Microneedling

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Fractional non-ablative 1,540nm laser

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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DermaPen 3MD Palomar StarLux

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hye Jin Chung, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

Boston University Department of Dermatology

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-37256

Identifier Type: -

Identifier Source: org_study_id

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