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Related Studies
Laser Treatment for Fresh Surgical Scars and Mature Scars
This study has been terminated.
( Poor enrollment )

First Received on December 10, 2009.   Last Updated on August 31, 2011   History of Changes
Sponsor: ConBio, a Cynosure Company
Information provided by: ConBio, a Cynosure Company
ClinicalTrials.gov Identifier: NCT01030198
  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:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by ConBio, a Cynosure Company:

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 ]

Estimated 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
Active Comparator: Fresh surgical scars Device: RevLite (Laser Treatment)
Active Comparator: Mature scars Device: RevLite (Laser Treatment)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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
ConBio, a Cynosure Company
  More Information

No publications provided

Responsible Party: HOYA ConBio, Inc. (Jim Green, VP Research and Development)
ClinicalTrials.gov Identifier: NCT01030198     History of Changes
Other Study ID Numbers: C68-08-S
Study First Received: December 10, 2009
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012



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