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

NCT03514771 | Completed

• 1 other identifier: IRB_00087490
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (1)

• 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).

  Adverse Events

  Baseline visit through 4 month follow-up

Secondary Outcomes (1)

• To evaluate the efficacy of 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).

  up to 4-months follow up

Study Arms (1)

All Subjects

OTHER

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

Device: Fraxel DUAL 1550/1927; Drug: oral isotretinoin; Drug: oral valacyclovir

Interventions

Fraxel DUAL 1550/1927 DEVICE

All Subjects

oral isotretinoin DRUG

oral isotretinoin

All Subjects

oral valacyclovir DRUG

Oral valacyclovir

All Subjects

Eligibility Criteria

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

You may qualify if:

• years or older
• Completed cumulative dose of \>=120 miligram/kilogram oral isotretinoin within the last 30 days
• Mild-moderate acne scarring of all types (icepick, boxcar, rolling)

You may not qualify if:

• Pregnant or nursing women
• History of porphyria, allergy to porphyrins, or photodermatosis
• Active infectious disease
• Severe acne scarring
• Propensity to hypertrophic or keloid scarring
• Immunosuppression
• Laser or any cosmetic treatment in the previous 6 months

Sponsors & Collaborators

• David Smart: lead

MeSH Terms

Conditions

Hypertrophy

Interventions

Isotretinoin; Valacyclovir

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Efficacy evaluations of photographs will be performed by two trained and experienced evaluators who are blinded to which side of the face has been treated, and which side of the face has not been treated.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All subjects will have one side of the face (Right-Left) treated with the laser and the other side will be untreated to act as a control.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: May 2, 2018
• Study Start: January 28, 2016
• Primary Completion: March 14, 2017
• Study Completion: June 14, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share