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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fractionated laser
Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
Dermabrasion
Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.

Locations

Country Name City State
United States Zel Skin and Laser Edina Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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
3 months
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