Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening (IH062905)
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Purpose
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 |
|---|---|---|
|
Cellulite |
Device: 1064 nm Nd:YAG laser |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening |
- Celluite skin tightening [ Time Frame: 1, 3, 6 month follow up ] [ Designated as safety issue: No ]
- Safety and efficacy of laser with and without cooling [ Time Frame: Laser Treatments x3 and at 1, 3 and 6 month follow up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2006 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Laser treatment with cooling
|
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
Other Name: Candela Gentle YAG Laser
|
|
Active Comparator: 2
Laser treatment without cooling
|
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
Other Name: Candela Gentle YAG Laser
|
Detailed Description:
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.
- The primary objective is to assess the safety and efficacy of the laser for skin tightening.
- The secondary objective is to assess the safety and efficacy of the laser with cooling and the laser without cooling for skin tightening.
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Individuals, male or female, greater than 40 years of age.
- Moderate skin laxity in the arms, legs, abdomen, or neck.
- Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27.
- Subject has Fitzpatrick skin phototype I-IV.
- Subject is willing to participate in study and adhere to follow-up schedule.
- Subject is able to read and comprehend English.
- Subject has completed Informed Consent Form.
Exclusion Criteria:
- Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year.
- Subject is overweight (BMI > 27).
- Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months.
- Subject has a personal or family history of keloid formation or scarring.
- Subject is pregnant or lactating.
- Subject has a history of uncontrolled diabetes and/or requires medication which may interfere with the study.
- Subjects with a known history of neuropathy.
- Subjects with a known history of a coagulopathy.
- Subject is unable or unwilling to comply with the study requirements
- Subject has pacemaker or metallic implants.
- Subject has Fitzpatrick skin type V and VI.
- Subject is mentally incompetent or a prisoner.
Contacts and Locations| United States, California | |
| UC Irvine Beckman Laser Institute | |
| Irvine, California, United States, 92697 | |
| UC Irvine Dermatology Clinical Research Center | |
| Irvine, California, United States, 92697 | |
| Principal Investigator: | Kristen M Kelly, M.D. | University of California, Irvine |
More Information
Additional Information:
Publications:
| Responsible Party: | Kristen M. Kelly, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00585715 History of Changes |
| Other Study ID Numbers: | 2006-5138, No. 062905 |
| Study First Received: | December 26, 2007 |
| Last Updated: | June 23, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Irvine:
|
Cellulite Nd:YAG Laser |
ClinicalTrials.gov processed this record on May 23, 2013