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

NCT ID: NCT00585715

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-01-31

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.

Conditions

Localized Lipodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Candela DCD with cooling

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.

Group Type: EXPERIMENTAL

1064 nm Nd:YAG laser

Intervention Type: DEVICE

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

Candela DCD without Cooling

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.

Group Type: ACTIVE_COMPARATOR

1064 nm Nd:YAG laser

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Candela Gentle YAG Laser

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Candela Corporation

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Kristen Kelly, M.D Associate Professor Departments of Dermatology and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristen M Kelly, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Beckman Laser Institute

Irvine, California, United States

UC Irvine Dermatology Clinical Research Center

Irvine, California, United States

Countries

United States

References

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.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://www.dermatology.uci.edu/clinical_research.html

UC Irvine Department of Dermatology Clinical Research

http://www.bli.uci.edu/

Beckman Laser Institute

Other Identifiers

062905

Identifier Type: OTHER

Identifier Source: secondary_id

UCIaward#062905

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20065138

Identifier Type: -

Identifier Source: org_study_id