An interventional study of 1064 nm Nd:YAG laser in Localized Lipodystrophy, sponsored by University of California, Irvine. Completed at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 22 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Also known as: Candela Gentle YAG Laser
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
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
| Milestone | Laser With Cooling | Laser Without Cooling |
|---|---|---|
| Started | 11 | 11 |
| Completed | 8 | 11 |
| Not completed | 3 | 0 |
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.
| participants | Laser With Cooling for Skin Tightening | Laser Without Cooling for Skin Tightening |
|---|---|---|
| Number of Participants With Mild to Moderate Reduction in Cellulite. | 3 | 2 |
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.
| units on a scale | Laser With Cooling for Skin Tightening | Laser Without Cooling for Skin Tightening |
|---|---|---|
| Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. | 1 ± 0 | 2 ± 0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laser With Cooling | — | 0/8 (0%) | 0/8 (0%) |
| Laser Without Cooling | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Laser With Cooling | Laser Without Cooling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 11 | 22 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Laser With Cooling | Laser Without Cooling | Total |
|---|---|---|---|
| Mean | 38 ± 9.47724547 | 36 ± 8.40346249 | 37 ± 8.77225062 |
| Sex: Female, Male(Participants) | Laser With Cooling | Laser Without Cooling | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Laser With Cooling | Laser Without Cooling | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
Plan to share: No
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