Clinical trial NCT00585715: Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening
Official title: Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Localized Lipodystrophy
Keywords: Cellulite
Nd:YAG Laser
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Candela Corporation
First posted: 2008-01-03
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Mild to Moderate Reduction in Cellulite.
timeFrame: 6 month follow up
measure: Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.
timeFrame: 6 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
city: Irvine
country: United States
facility: UC Irvine Dermatology Clinical Research Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Kristen M Kelly, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.