Status:
TERMINATED
Scar Prevention Using Fractional Carbon Dioxide Laser Treatment
Lead Sponsor:
Lumenis Be Ltd.
Conditions:
Scar Prevention
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study the investigators intend to determine the impact of fractional CO2 laser treatment on the edges of a fresh wound during surgical area closure on thin skin (e.g. face, hands, arms, thorax...
Eligibility Criteria
Inclusion
- Male or Females
- At least 18 and no more than 65 years old
- The surgical area closure in these subjects should be at least 4cm
- Type of surgery scheduled:
- Site 1: Surgical area closure on thin skin, including areas that require motion (e.g. face, hands, arms, thorax, etc.) Site 2: Surgical area closure on thick skin (abdominoplasty procedure)
- Willing to comply with study dosing and complete the entire course of the study
Exclusion
- Active bacterial, fungal, or viral infection in the treatment area
- Active cold sores, or herpes in the treatment area
- Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
- History of skin cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis)
- Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
- History or presenting with a keloid scar
- Any current or recent treatment for cancer, unless the surgical procedure of issue is for cancer treatment purposes.
- Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator
- Female subject who is pregnant, nursing an infant or is less than 6 months after termination of breast feeding
- Small surgical closure (\<4cm)
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01826942
Start Date
January 1 2013
End Date
March 1 2013
Last Update
March 26 2014
Active Locations (1)
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1
Ronald L. Moy, M.D.
Beverly Hills, California, United States, 90210