Laser Treatment for Fresh Surgical Scars and Mature Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030198
Recruitment Status : Terminated (Poor enrollment)
First Posted : December 11, 2009
Last Update Posted : November 28, 2012
Information provided by (Responsible Party):
Cynosure, Inc.

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.

Condition or disease Intervention/treatment Phase
Fresh Surgical Scars Mature Scars Device: RevLite (Laser Treatment) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fresh surgical scars
Treatment of scars
Device: RevLite (Laser Treatment)
Experimental: Mature scars
Treatment of scars
Device: RevLite (Laser Treatment)

Primary Outcome Measures :
  1. Assessment of improvement in scar appearance, vascularity, height, pliability, pigmentation and any pre-existing pruritis [ Time Frame: 1 month post final treatment (fresh scars) or 3 and 6 months post final treatment (mature scars) ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030198

United States, Florida
Sanctuary Medical Aesthetic Center
Boca Raton, Florida, United States, 33431
Sponsors and Collaborators
Cynosure, Inc.

Responsible Party: Cynosure, Inc. Identifier: NCT01030198     History of Changes
Other Study ID Numbers: C68-08-S
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012