Determination of Safety and Efficacy of a Laser With Cooling for Treatment of Skin
This study has been completed.
Information provided by (Responsible Party):
First received: May 9, 2006
Last updated: August 2, 2012
Last verified: August 2012
The appearance of aged skin is a common cosmetic complaint of middle aged and older individuals. This study evaluates the safety and efficacy of a new laser with cooling to improve the appearance of aged skin. The laser being used will heat various depths of the skin while protecting the outer layer.
Device: dermatological infrared laser
||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Primary Outcome Measures:
- score on a grading scale at post treatment visits
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2006 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Aged skin, light to medium skin types.
Known photosensitivity Any of the following pre-existing skin conditions: eczema, psoriasis, allergic dermatitis or other conditions that may affect treatment.
Other treatments within the past year for aged facial skin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323921
||E. V. Ross, M.D.
||United States Naval Medical Center, San Diego
No publications provided
ClinicalTrials.gov processed this record on December 09, 2013
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 9, 2006
||August 2, 2012
||United States: Food and Drug Administration