Clinical trial NCT01030198: Laser Treatment for Fresh Surgical Scars and Mature Scars
Official title: Post-Market, Two-Arm, Single Blind, Controlled Study of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminum Garnet (EO QS Nd:YAG) Laser System for the Treatment of Scars
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: New Surgical Scars
Scars
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assessment of Improvement in Scar Appearance, Vascularity, Height, Pliability, Pigmentation and Any Pre-existing Pruritis
timeFrame: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars)
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Sanctuary Medical Aesthetic Center
state: Florida
Study officials:
References: