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Trial record 12 of 83 for:    acne AND Acne Scars

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

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ClinicalTrials.gov Identifier: NCT03514771
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
David Smart, University of Utah

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.

Condition or disease Intervention/treatment Phase
Acne Scars - Mixed Atrophic and Hypertrophic Device: Fraxel DUAL 1550/1927 Drug: oral isotretinoin Drug: oral valacyclovir Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin
Actual Study Start Date : January 28, 2016
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
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.
Device: Fraxel DUAL 1550/1927
Drug: oral isotretinoin
oral isotretinoin

Drug: oral valacyclovir
Oral valacyclovir




Primary Outcome Measures :
  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). [ Time Frame: Baseline visit through 4 month follow-up ]
    Adverse Events


Secondary Outcome Measures :
  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). [ Time Frame: up to 4-months follow up ]
    To compare acne improvement using a quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76%). improvement). Photos taken at each treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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)

Exclusion Criteria:

  • 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

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Responsible Party: David Smart, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03514771     History of Changes
Other Study ID Numbers: IRB_00087490
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical
Valacyclovir
Isotretinoin
Antiviral Agents
Anti-Infective Agents
Dermatologic Agents