Cicatrix Clinical Trial
Official title:
A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision
NCT number | NCT01176448 |
Other study ID # | 1001M75732-2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2010 |
Est. completion date | September 2010 |
Verified date | October 2019 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Post-surgical or post traumatic scar on face or scalp. - Age 18 or older - Able to read and comprehend English - Willing to follow treatment schedule and post treatment care requirements - Signed the informed consent form - Fitzpatrick skin type I-III Exclusion Criteria: - known photosensitivity - Taken any medications known to induce photosensitivity in previous three months - Taken Accutane within past 12 months - Pregnant or nursing - Currently on topical or oral antibiotics - Immunocompromised status - Skin type IV or greater |
Country | Name | City | State |
---|---|---|---|
United States | Zel Skin and Laser | Edina | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe. | Day 0, Week1, Month 1 | |
Secondary | Visual Analog Scale for Assessing Scar Improvement. | Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement : 1-25% improvement : 26-50% improvement : 51-75% improvement : 76-100% improvement |
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