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

Not Applicable

Completed

• Conditions: Localized Lipodystrophy

• Registration Number: NCT00585715
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2008-01-03
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Results First Submitted: 2011-06-17
• Results First Submitted QC: 2013-10-24
• Results First Posted: 2013-12-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Beckman Laser Institute; 🇺🇸 Irvine, California, United States

UC Irvine Dermatology Clinical Research Center; 🇺🇸 Irvine, California, United States