Laser Treatment for Fresh Surgical Scars and Mature Scars

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01030198
First received: December 10, 2009
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention
Fresh Surgical Scars
Mature Scars
Device: RevLite (Laser Treatment)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Cynosure, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh surgical scars
Treatment of scars
Device: RevLite (Laser Treatment)
Experimental: Mature scars
Treatment of scars
Device: RevLite (Laser Treatment)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030198

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

No publications provided

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT01030198     History of Changes
Other Study ID Numbers: C68-08-S
Study First Received: December 10, 2009
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014