Laser Treatment for Fresh Surgical Scars and Mature Scars

NCT ID: NCT01030198

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

New Surgical Scars; Scars

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fresh surgical scars

Treatment of scars

Group Type: EXPERIMENTAL

RevLite (Laser Treatment)

Intervention Type: DEVICE

Mature scars

Treatment of scars

Group Type: EXPERIMENTAL

RevLite (Laser Treatment)

Intervention Type: DEVICE

Interventions

RevLite (Laser Treatment)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sanctuary Medical Aesthetic Center

Boca Raton, Florida, United States

Countries

United States

Other Identifiers

C68-08-S

Identifier Type: -

Identifier Source: org_study_id