Laser Treatment for Fresh Surgical Scars and Mature Scars

Scars Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01030198
• Other study ID #: C68-08-S
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• New Surgical Scars
• Scars

Intervention

Device:
• RevLite (Laser Treatment)

Locations

Country	Name	City	State
United States	Sanctuary Medical Aesthetic Center	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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