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

Localized Lipodystrophy Clinical Trial

— IH062905  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585715
• Other study ID #: 20065138
• Secondary ID: 062905UCIaward#0
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: January 2010

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lipodystrophy
• Localized Lipodystrophy

Intervention

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

Locations

Country	Name	City	State
United States	Beckman Laser Institute	Irvine	California
United States	UC Irvine Dermatology Clinical Research Center	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Candela Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 month follow up
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.	6 month follow up

External Links

•   Beckman Laser Institute