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

NCT03901417 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-01-28

No results posted yet for this study

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

Interventions

DEVICE

Fraxel Restore (Non-ablative Fractional Laser)

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

DEVICE

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Mathew Avram, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-06-30
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901417 on ClinicalTrials.gov