Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening (IH062905)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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 Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
![]() |
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 | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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
Adverse Events
Limitations and Caveats
Small sample size
More Information
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 |