Acne Scarring in Skin of Color: Laser vs Microneedling

NCT03395678 | Withdrawn FDA Device

• 1 other identifier: H-37256
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris; Scar

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Treatment satisfaction

  3 months after the last/5th treatment

• Impact of skin disease on the quality of life

  3 months after the last/5th treatment

Study Arms (2)

Microneedling

EXPERIMENTAL

Participants in this arm will receive 5 treatments of microneedling.

Device: Microneedling

Fractional non-ablative 1,540nm laser

ACTIVE COMPARATOR

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

Device: Fractional non-ablative 1,540nm laser

Interventions

Microneedling 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.

Also known as: DermaPen 3MD

Microneedling

Fractional non-ablative 1,540nm laser 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.

Also known as: Palomar StarLux

Fractional non-ablative 1,540nm laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Interventions

Percutaneous Collagen Induction; Lasers

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Hye Jin Chung, MD, MMS

  Boston University Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: November 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)