Laser Treatment for Fresh Surgical Scars and Mature Scars

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis	1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)	The number of participants who experienced improvements in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis will be counted.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Sanctuary Medical Aesthetic Center
🇺🇸
Boca Raton, Florida, United States
Sanctuary Medical Aesthetic Center
🇺🇸Boca Raton, Florida, United States