Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars

NCT03901417 | Unknown DMC FDA Device

• 1 other identifier: 2018P002595
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Acne scarring is an unfortunate consequence of inflammatory acne vulgaris that often leads to significant cosmetic and psychosocial impacts. Although there have been many advances in the treatment of acne scarring, it remains one of the greatest challenges in cosmetic and laser dermatology. There have been a multitude of studies establishing the efficacy of non-ablative fractional laser therapy for the treatment of atrophic acne scars, and it is widely regarded as one of the best available treatments. More recently, there has been a renewed interest in controlled, non-thermal dermal injury via microneedling devices in the treatment of atrophic acne scars. Where there is a gap in the literature, however, is in the evaluation of the combination of non-ablative fractional laser resurfacing with microneedling in the treatment of atrophic acne scars. The investigators' study will compare the safety and efficacy of using non-ablative fractional laser versus a combination of microneedling and non-ablative fractional laser for atrophic acne scars using a randomized, double-blind, split-face study. The investigators' aim is to further elucidate the pathogenesis of acne scarring and the best approaches for treatment. In doing so, the investigators will study a combination approach to this complex problem in order to better serve future patients.

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Improvement in acne scarring

  Two blinded evaluators will use standardized digital photographic review to grade acne scar improvement on a quartile grading scale (1 = 1% to 25%, 2 = 26 to 50%, 3 = 51 to 75%, 4 = \>76% improvement).

  20 weeks

Study Arms (2)

Non-ablative Fractional Laser

ACTIVE COMPARATOR

Non-ablative fractional laser (brand name Fraxel Restore) only on one half of the face.

Device: Fraxel Restore (Non-ablative Fractional Laser)

Non-ablative Fractional Laser Plus Microneedling

ACTIVE COMPARATOR

Non-ablative fractional laser (brand name Fraxel Restore) in combination with a microneedling device (SkinPen) on the other half of the face.

Device: Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)

Interventions

Fraxel Restore (Non-ablative Fractional Laser) DEVICE

In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months.

Non-ablative Fractional Laser

Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device) DEVICE

In the study, one side of the face will be treated with a combination of non-ablative fractional laser and microneedling monthly for three months.

Non-ablative Fractional Laser Plus Microneedling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All gender patients
• Age older than 18 years
• Fitzpatrick skin types I-III
• Facial acne scarring of grades III-IV
• Both sides of the face should have similar amount and severity of acne scarring

You may not qualify if:

• History of keloidal scarring
• Localized or active infection in the treatment region
• Immunodeficiency disorders
• Porphyria or light sensitivity
• Connective tissue disorders.
• Pregnant or nursing
• Recent isotretinoin use within the past 6 months
• Renal Disease
• Allergies to lidocaine, tetracaine, valacyclovir

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Mathew Avram, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dermatologic Surgery and Laser and Cosmetic Center

Model Details: Randomized split-face clinical trial

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 3, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)