- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641420
Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.
Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.
Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
- Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
- Patients able to follow instructions
- If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
- Written informed consent from the patients (Appendix II)
Exclusion Criteria:
- Children (less than 18 years old)
- Pregnant or lactating women
- Personal history of keloids or hypertrophic scarring
- Active acne requiring topical or oral therapy
- Accutane or other oral retinoid in past year
- Patients with a known allergy to lidocaine
- Allergy to valacyclovir in a patient that needs prophylaxis
- Patients with an unstable or non controlled underlying medical problem
- Patients who are not able to follow instructions
- Patients who have participated in a study within the 3 months prior to study entry
- Patients who refuse to give written informed consent
- Patients with a history of a pigmentary abnormality
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fractional Laser 10mJ
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
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Other Names:
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Experimental: Fractional Laser 40mJ
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in acne scarring.
Time Frame: 6 months
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Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspigmentation
Time Frame: 6 months
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dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.
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6 months
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Pain with treatment
Time Frame: 5 months
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subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain
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5 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David M Ozog, MD, Henry Ford Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HenryFord4447
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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