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

• 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: University of California, Irvine
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Laser With Cooling	Laser Without Cooling
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

Baseline Characteristics

Arm/Group Title		Laser With Cooling	Laser Without Cooling	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Mild to Moderate Reduction in Cellulite.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	There were no adverse events reported.
Arm/Group Title	Laser With Cooling	Laser Without Cooling
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	--/--	--/--
Serious Adverse Events
	Laser With Cooling	Laser Without Cooling
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/8 (0.00%)	0/11 (0.00%)
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%)

Limitations and Caveats

Small sample size

More Information

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

• 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.

• 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