Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin

Sponsor
David Smart
Study ID
NCT03514771
Status
Completed

Conditions

  • Acne Scars - Mixed Atrophic and Hypertrophic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fraxel DUAL 1550/1927 — DEVICE
  • oral isotretinoin — DRUG
    oral isotretinoin
  • oral valacyclovir — DRUG
    Oral valacyclovir

Study Details

Patients who have completed have completed a cumulative dose of \>=120miligram/kilogram oral isotretinoin within the last 30 days, and has mild to moderate acne scarring will be randomized, into a right-left comparison study using Fraxel DUAL (Solta Medical) laser on one side of the face, and no treatment on the other side of the face. Subejcts will receive treatments at week 0, week 4, and week 8. Photographs will be taken after each treatment, 7 days after each treatment, and 4 months after last treatment. Photographs will be reviewed by blind assessors who will analyze the pre- and post-treatment photographs to measure change.

Key Dates

Start date
Jan 28, 2016
Status verified
May 2018
Primary completion
Mar 14, 2017
Completion
Jun 14, 2017

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: All Subjects
    All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.

Primary Outcome Measure

The adverse events associated with early non-ablative fractional laser resurfacing (NAFR) for mild-moderate acne scars after treatment with oral isotretinoin compared to control (non-treated side of the face). [ Time Frame: Baseline visit through 4 month follow-up ]

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