Laser Treatment for Fresh Surgical Scars and Mature Scars

Stopped early · Not applicable

Conditions studied: New Surgical Scars, Scars

In brief

The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.

Key facts

Study ID

NCT01030198

Run by

Cynosure, Inc.

People needed

7

Starts

2010-01-01

Expected to finish

2010-12-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present [or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
• Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)

You may not qualify if…

• Pregnant, lactating, or is planning to become pregnant
• history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
• any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
• coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
• any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
• currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
• unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
• unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
• Isotretinoin therapy within 6 months
• need to be exposed to artificial tanning devices or excessive sunlight during the trial
• prior treatment with parenteral gold therapy
• does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
• Diabetes Type 1 or 2
• Lupus, scleroderma or similar immune system disorder
• underlying silicone or other non-absorbable filler in the area of the scar
• phenol chemical peel or dermabrasion to the area of the scar within 3 months
• Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient

Where it is running

• Sanctuary Medical Aesthetic Center — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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