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| ID | Type | Description | Link |
|---|---|---|---|
| 062905 | Other Identifier | University of California, Irvine | |
| UCIaward#062905 | Other Grant/Funding Number | Candela Corporation |
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| Name | Class |
|---|---|
| Candela Corporation | INDUSTRY |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candela DCD with cooling | Experimental | 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. |
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| Candela DCD without Cooling | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1064 nm Nd:YAG laser | Device | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen M Kelly, M.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Laser Institute | Irvine | California | 92697 | United States | ||
| UC Irvine Dermatology Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Truitt, A., Echague, A., Zachary, C. Kelly K.M. Evaluation of the Candela 1064 nm Nd:YAG Laser for Cellulite and Skin Tightening. Presented at the American Society for Laser Medicine and Surgery Annual Meeting, 2007, Dallas, TX. |
| Label | URL |
|---|---|
| UC Irvine Department of Dermatology Clinical Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser With Cooling | Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
| FG001 | Laser Without Cooling | Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser With Cooling | Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
| BG001 | Laser Without Cooling |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only subjects who completed the 6 month follow-up were included in the analysis | Posted | Number | participants | 6 month follow up |
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There were no adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser With Cooling | Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
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Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen M. Kelly, M.D. | University of California, Irvine | 949-824-7103 | kmkelly@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2009 | Feb 1, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Irvine |
| California |
| 92697 |
| United States |
| Beckman Laser Institute | View source |
Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Laser With Cooling for Skin Tightening | Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
| OG001 | Laser Without Cooling for Skin Tightening | Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. |
|
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| Primary | 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. | The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance. | Posted | Mean | Standard Deviation | units on a scale | 6 month follow up |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Laser Without Cooling | Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. | 0 | 11 | 0 | 11 |
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