NCT00585715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

December 16, 2013

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

3.2 years

First QC Date

December 26, 2007

Results QC Date

June 17, 2011

Last Update Submit

October 19, 2022

Conditions

Localized Lipodystrophy

Keywords

CelluliteNd:YAG Laser

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Candela DCD with cooling

EXPERIMENTAL

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

Candela DCD without Cooling

ACTIVE COMPARATOR

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

Interventions

1064 nm Nd:YAG laserDEVICE

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

Also known as: Candela Gentle YAG Laser
Candela DCD with coolingCandela DCD without Cooling

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute

Irvine, California, 92697, United States

Location

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Related 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.

    RESULT

Related Links

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size

Results Point of Contact

Title
Kristen M. Kelly, M.D.
Organization
University of California, Irvine
kmkelly@uci.edu
949-824-7103

Study Officials

  • Kristen M Kelly, M.D.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kristen Kelly, M.D Associate Professor Departments of Dermatology and Surgery

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 3, 2008

Study Start

October 1, 2006

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

October 21, 2022

Results First Posted

December 16, 2013

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)