Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fraxel DUAL 1550/1927
oral isotretinoin
oral valacyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Subjects
Arm Description
All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514771
Brief Title
Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin
Official Title
Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2016 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Smart
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Approximately 15 patients who are over 18 years or older, 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.
One side of the face will be randomized to NAFR treatment and other side to control (no treatment) using a random number generator. Subjects will apply topical anesthetic (Benzocaine / Lidocaine / Tetracaine 20% / 8% / 4% Ointment) to the entire face one hour prior to treatment. The NAFR operator will be notified of which side is to be treated with NAFR.
To ensure blinded evaluations, the same unblinded investigator will perform all the laser treatments, whereas efficacy evaluations will be performed by two trained and experienced evaluators who are blinded to the treatment assignment. Evaluations for adverse effects will be carried out by the unblinded NAFR (during and immediately post treatment) and the two blinded investigators at prescribed intervals.
Treatments:
Laser procedure will be performed to the entire assigned half of the face with Fraxel DUAL (Solta Medical) with the following settings: 1550 nanometer; 35 to 40 millijoules/microthermal zone, treatment level from 7 to 10, corresponding to treatment coverage of 20% to 35%. The treatment protocol was modified slightly depending on the individual scar characteristics (depth, width, and type).
The patients will receive a total of three laser treatments using NAFR. Successive treatments will be separated by 1 month. During all treatments, pain will be assessed as ''mild, moderate, or severe.'' Post-treatment instructions will include the use of a mild soap, sunscreen in the morning, and a non-comedogenic moisturizing cream in the evening twice daily for three days. Oral valacyclovir (1 gram daily) will be prescribed for patients for prophylaxis of herpetic infection.
Evaluations:
Photographic documentation using identical camera settings, lighting, and patient positioning will be obtained at baseline, before each treatment session, 7-days after each session, and 4 months after the final treatment.
Primary Efficacy Measure:
Wound healing will be assessed after 7 days of each treatment and at the end of the study (4 month after last treatment) in all patients. This will be performed by 2 blinded evaluators who will analyze the pre and post-treatment photographs.
Secondary Efficacy Measure:
Secondary study endpoints will be improvement of acne scarring, assessment of treatment tolerability (adverse effects, pain assessment, and patient satisfaction and preference.
Improvement in acne scarring will be graded by two independent blinded physicians using a quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76%). All grading physicians will be blinded to the total number of treatments and which photographs were baseline and follow-up at 4 month after last treatment.
Evaluations for immediate and delayed adverse effects of the treatments, including erythema, edema, blistering, crusting, scarring, and hyperpigmentation, graded on a 4-point scale (0 = absent, 1= mild, 2 = moderate, and 3 = severe) will be carried out at each visit.
Patients will also assess the intensity of pain post-treatment using a visual analogue scale (VAS) (0 = absence of pain, 10 = most-severe pain).
Patient assessment of efficacy would be reflected by their judgment of which side of the face responded best to treatment. Patient preference can then be assessed at the end of the study asking, "would you recommend NAFR treatment for acne scarring to others?"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
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.
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Subjects
Arm Type
Other
Arm Description
All subjects will have one side of their face treated with the laser and one side not treated to serve as the control.
Intervention Type
Device
Intervention Name(s)
Fraxel DUAL 1550/1927
Intervention Type
Drug
Intervention Name(s)
oral isotretinoin
Intervention Description
oral isotretinoin
Intervention Type
Drug
Intervention Name(s)
oral valacyclovir
Intervention Description
Oral valacyclovir
Primary Outcome Measure Information:
Title
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).
Description
Adverse Events
Time Frame
Baseline visit through 4 month follow-up
Secondary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
up to 4-months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Non-Ablative Fractional Laser Resurfacing for Acne Scars After Treatment With Oral Isotretinoin
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