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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 9, 2006
||August 2, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014