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

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ClinicalTrials.gov Identifier: NCT00585715
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : December 16, 2013
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Candela Corporation
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Localized Lipodystrophy
Intervention Device: 1064 nm Nd:YAG laser
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser With Cooling Laser Without Cooling
Hide Arm/Group Description Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Period Title: Overall Study
Started 11 11
Completed 8 11
Not Completed 3 0
Arm/Group Title Laser With Cooling Laser Without Cooling Total
Hide Arm/Group Description Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
11
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
38  (9.47724547) 36  (8.40346249) 37  (8.77225062)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
11
 100.0%
11
 100.0%
22
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Number of Participants With Mild to Moderate Reduction in Cellulite.
Hide Description

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.

Time Frame 6 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects who completed the 6 month follow-up were included in the analysis
Arm/Group Title Laser With Cooling for Skin Tightening Laser Without Cooling for Skin Tightening
Hide Arm/Group Description:
Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Overall Number of Participants Analyzed 7 9
Measure Type: Number
Unit of Measure: participants
3 2
2.Primary Outcome
Title Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction.
Hide Description

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.

Time Frame 6 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The average amount of cellulite reduction was calculated from the 5 subjects who experienced mild to moderate improvement in cellulite appearance.
Arm/Group Title Laser With Cooling for Skin Tightening Laser Without Cooling for Skin Tightening
Hide Arm/Group Description:
Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (0) 2  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description There were no adverse events reported.
 
Arm/Group Title Laser With Cooling Laser Without Cooling
Hide Arm/Group Description Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments. Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
All-Cause Mortality
Laser With Cooling Laser Without Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Laser With Cooling Laser Without Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Laser With Cooling Laser Without Cooling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristen M. Kelly, M.D.
Organization: University of California, Irvine
Phone: 949-824-7103
EMail: kmkelly@uci.edu
Publications of Results:
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.
Layout table for additonal information
Responsible Party: Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585715    
Other Study ID Numbers: 2006-5138
062905 ( Other Identifier: University of California, Irvine )
UCIaward#062905 ( Other Grant/Funding Number: Candela Corporation )
First Submitted: December 26, 2007
First Posted: January 3, 2008
Results First Submitted: June 17, 2011
Results First Posted: December 16, 2013
Last Update Posted: May 7, 2020