Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening (IH062905)

This study has been completed.
Sponsor:
Collaborator:
Candela Corporation
Information provided by (Responsible Party):
Kristen Kelly, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585715
First received: December 26, 2007
Last updated: October 24, 2013
Last verified: October 2013
  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
Localized Lipodystrophy
Device: 1064 nm Nd:YAG laser
Phase 1
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Mild to Moderate Reduction in Cellulite. [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

    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.


  • Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. [ Time Frame: 6 month follow up ] [ Designated as safety issue: No ]

    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.



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 ]

Enrollment: 22
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: 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.
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: 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.
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 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UC Irvine Dermatology Clinical Research Center
Irvine, California, United States, 92697
Beckman Laser Institute
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:
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 Kelly, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585715     History of Changes
Other Study ID Numbers: 2006-5138, 062905, UCIaward#062905
Study First Received: December 26, 2007
Results First Received: June 17, 2011
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
Cellulite
Nd:YAG Laser

Additional relevant MeSH terms:
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014