Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening - Full Text View

Sponsor:	University of California, Irvine
Collaborator:	Candela Corporation
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00585715

Purpose

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.

Condition	Intervention	Phase
Cellulite	Device: 1064 nm Nd:YAG laser	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Celluite skin tightening [ Time Frame: 1, 3, 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and efficacy of laser with and without cooling [ Time Frame: Laser Treatments x3 and at 1, 3 and 6 month follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	October 2006
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Laser treatment with cooling	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 Other Name: Candela Gentle YAG Laser
Active Comparator: 2 Laser treatment without cooling	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 Other Name: Candela Gentle YAG 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 arms, legs, abdomen, and neck.

The primary objective is to assess the safety and efficacy of the laser for skin tightening.
The secondary objective is to assess the safety and efficacy of the laser with cooling and the laser without cooling for skin tightening.

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals, male or female, greater than 40 years of age.
Moderate skin laxity in the arms, legs, abdomen, or neck.
Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27.
Subject has Fitzpatrick skin phototype I-IV.
Subject is willing to participate in study and adhere to follow-up schedule.
Subject is able to read and comprehend English.
Subject has completed Informed Consent Form.

Exclusion Criteria:

Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year.
Subject is overweight (BMI > 27).
Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months.
Subject has a personal or family history of keloid formation or scarring.
Subject is pregnant or lactating.
Subject has a history of uncontrolled diabetes and/or requires medication which may interfere with the study.
Subjects with a known history of neuropathy.
Subjects with a known history of a coagulopathy.
Subject is unable or unwilling to comply with the study requirements
Subject has pacemaker or metallic implants.
Subject has Fitzpatrick skin type V and VI.
Subject is mentally incompetent or a prisoner.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585715

Locations

United States, California
UC Irvine Beckman Laser Institute
Irvine, California, United States, 92697
UC Irvine Dermatology Clinical Research Center
Irvine, California, United States, 92697

Sponsors and Collaborators

University of California, Irvine

Candela Corporation

Investigators

Principal Investigator:

Kristen M Kelly, M.D.

University of California, Irvine

More Information

Additional Information:

UC Irvine Department of Dermatology Clinical Research This link exits the ClinicalTrials.gov site

Beckman Laser Institute This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Kristen M. Kelly, MD, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00585715 History of Changes
Other Study ID Numbers:	2006-5138, No. 062905
Study First Received:	December 26, 2007
Last Updated:	June 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Irvine:

Cellulite
Nd:YAG Laser

ClinicalTrials.gov processed this record on February 09, 2012