Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening

Study Overview
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Brief Summary
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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.

Detailed Description
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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 thighs. The primary objective is to assess the safety and efficacy of the laser for improvement in appearance of cellulite. The secondary objective is to assess the safety and efficacy of the laser with cooling and the laser without cooling for improvement in appearance of cellulite. 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.

Official Title
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Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening

Conditions
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Localized Lipodystrophy

Intervention / Treatment
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* Device: 1064 nm Nd:YAG laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candela DCD with cooling<br>Laser treatment with Candela DCD cooling which produces a cryogenic fluid that cools the epidermis prior to each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will receive a coolant during the laser procedure. | Device: 1064 nm Nd:YAG laser<br>* 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<br>* Other names: Candela Gentle YAG Laser;|
| Active Comparator: Candela DCD without Cooling<br>Laser treatment without cooling before each laser pulse. Treatment will be conducted on either the left or the right thigh, which will also be randomly determined. The contra-lateral side will not be treated and will serve as a control. The laser system to be used in is Candela GentleYAG, a 1064nm Nd:YAG laser. This arm will not receive a coolant during the laser procedure. | Device: 1064 nm Nd:YAG laser<br>* 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<br>* Other names: Candela Gentle YAG Laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Mild to Moderate Reduction in Cellulite. | Nurnberger-Muller Scale : Stage 0: No dimpling. Stage 1: No dimpling. Stage 2: Dimpling spontaneously standing. Stage 3: Dimpling spontaneously standing and lying down. Texture Scale: Hard or Solid: Pinch test firm folds and furrows. Adherent to deep planes. Not modified with lying versus standing position. Soft or Flaccid: Pinch test spongy and floating folds and furrows. No adherence to deep planes. Not painful, flaccid. Orange peel skin appears spontaneously. Edematous: Doughy consistency. Pain and cramps. Signs of venous and lymphatic insufficiency legs in boot/column. At the 6month follow-up, a blinded assessor ranked changes in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Improvement in cellulite appearance was characterized by an increase of one unit or more on this scale. | 6 month follow up | 
| Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. | At the 6 month follow-up, a blinded assessor ranked change in cellulite appearance on subject's thighs according to the prior cellulite dimpling and texture criteria. Change in cellulite appearance was assessed on a scale of 0-3, with 0 as no change and 3 as significant change. Using this scale, the average reduction in cellulite appearance was calculated for each participant that experienced a mild to moderate reduction in cellulite appearance. | 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellulite, Nd:YAG Laser