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Sponsors and Collaborators: |
University of California, Irvine Candela Corporation |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00585715 |
The purpose of this research study is to evaluate effectiveness of a non-ablative (does not remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using the Candela GentleYAG laser.
Condition | Intervention | Phase |
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Cellulite |
Device: 1064 nm Nd:YAG laser |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening |
Estimated Enrollment: | 25 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Laser treatment with cooling
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Device: 1064 nm Nd:YAG laser
3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms
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2: Active Comparator
Laser treatment without cooling
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Device: 1064 nm Nd:YAG laser
3 treatments at 3-5 week intervals Spot size: 10 - 18 mm diameter Fluence: 50 J/cm2 Laser pulse duration: 50 ms Rep. rate: Up to 2 Hz DCD cooling 0-50 ms
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The objective of this investigation is to evaluate the effectiveness of a non-ablative treatment for skin laxity by increasing dermatofibrosis of the reticular dermis using the Candela GentleYAG laser. Treatment areas will be limited to the arms, legs, abdomen, and neck.
This is an open label trial. Treatment will be conducted on either the left or the right thigh, which will be randomly determined. The contra-lateral side will not be treated and will serve as a control. A comparison of baseline photographs (prior to treatments) to photographs taken 1 and 3 months after the completion of treatments will be conducted. Photographic equipment and the protocol for photography will be consistent at each visit. Ultrasound may be taken at baseline and at the follow-up visits to evaluate flatness of cellulite and dermal fibrosis or enlargement of the reticular dermis. The circumference of the area to be treated will be measured with a tape measure, weight/height will be recorded and the Body Mass Index (BMI) will be calculated at baseline and follow-up visits. In addition, skin elasticity may be measured at the treatment areas at baseline and follow-up visits. The photographs, ultrasound and measurements will be taken using consistent procedures at each visit by viewing the baseline photograph and using landmarks such as freckles and birthmarks.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristen M Kelly, M.D. | 949-824-7103 | kmkelly@uci.edu |
Contact: Arisa Ortiz, M.D. | 949-824-7103 | arisao@uci.edu |
United States, California | |
UC Irvine Beckman Laser Institute | Recruiting |
Irvine, California, United States, 92697 | |
Contact: Montana Compton, R.N. 949-824-9265 mocomton@uci.edu | |
Principal Investigator: Kristen M Kelly, M.D. | |
UC Irvine Dermatology Clinical Research Center | Recruiting |
Irvine, California, United States, 92697 | |
Contact: Patty Summerville, CCRC 949-824-7103 psummerv@uci.edu | |
Contact: Arisa Ortiz, M.D. 949-824-7103 arisao@uci.edu |
Principal Investigator: | Kristen M Kelly, M.D. | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Kristen M. Kelly, MD ) |
Study ID Numbers: | 2006-5138, No. 062905 |
Study First Received: | December 26, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00585715 |
Health Authority: | United States: Food and Drug Administration |
Cellulite Nd:YAG Laser |