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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01409863
Other study ID # 1001M75732
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date March 2010

Study information

Verified date October 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.


Description:

Post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. The Fraxel Laser is a new FDA cleared treatment for textural irregularities of the skin. There have been no studies examining the efficacy of Fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." Dermabrasion is the gold standard for scar resurfacing and provides the criterion against which Fraxel therapy should be measured.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2010
Est. primary completion date March 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 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

Procedure:
laser and standard diamond fraise dermabrasion
standard dermabrasion, CO2 laser resurfacing

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Outcome

Type Measure Description Time frame Safety issue
Primary safety and efficacy of fractional photothermolysis compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision. Post Surgery
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