Localized Lipodystrophy
Conditions
Keywords
Cellulite, Nd:YAG Laser
Brief summary
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
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.
Interventions
DEVICE1064 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
Sponsors
Candela Corporation
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals, male or female, greater than 40 years of age. 2. Moderate skin laxity in the arms, legs, abdomen, or neck. 3. Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27. 4. Subject has Fitzpatrick skin phototype I-IV. 5. Subject is willing to participate in study and adhere to follow-up schedule. 6. Subject is able to read and comprehend English. 7. Subject has completed Informed Consent Form.
Exclusion criteria
1. Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year. 2. Subject is overweight (BMI \> 27). 3. Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months. 4. Subject has a personal or family history of keloid formation or scarring. 5. Subject is pregnant or lactating. 6. Subject has a history of uncontrolled diabetes and/or requires medication which may interfere with the study. 7. Subjects with a known history of neuropathy. 8. Subjects with a known history of a coagulopathy. 9. Subject is unable or unwilling to comply with the study requirements 10. Subject has pacemaker or metallic implants. 11. Subject has Fitzpatrick skin type V and VI. 12. Subject is mentally incompetent or a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Mild to Moderate Reduction in Cellulite. | 6 month follow up | 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. |
| Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. | 6 month follow up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Laser Without Cooling | Laser With Cooling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 8.40346249 | 38 years STANDARD_DEVIATION 9.47724547 | 37 years STANDARD_DEVIATION 8.77225062 |
| Region of Enrollment United States | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 0 / 8 | 0 / 11 |
Outcome results
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.
Time frame: 6 month follow up
Population: The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laser With Cooling for Skin Tightening | Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. | 1 units on a scale | Standard Deviation 0 |
| Laser Without Cooling for Skin Tightening | Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. | 2 units on a scale | Standard Deviation 0 |
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.
Time frame: 6 month follow up
Population: Only subjects who completed the 6 month follow-up were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser With Cooling for Skin Tightening | Number of Participants With Mild to Moderate Reduction in Cellulite. | 3 participants |
| Laser Without Cooling for Skin Tightening | Number of Participants With Mild to Moderate Reduction in Cellulite. | 2 participants |