Determination of Safety and Efficacy of a Laser With Cooling for Treatment of Skin

This study is ongoing, but not recruiting participants.

Sponsored by:	Candela Corporation
Information provided by:	Candela Corporation
ClinicalTrials.gov Identifier:	NCT00323921

Purpose

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.

Condition	Intervention
Aged Skin	Device: dermatological infrared laser

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Single Group Assignment

Further study details as provided by Candela Corporation:

Primary Outcome Measures:

score on a grading scale at post treatment visits

Estimated Enrollment:	75
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion:

Aged skin, light to medium skin types.

Exclusion:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323921

Sponsors and Collaborators

Candela Corporation

Investigators

Principal Investigator:

E. V. Ross, M.D.

San Diego Naval Medical Center

More Information

Study ID Numbers:	052603
Study First Received:	May 9, 2006
Last Updated:	May 9, 2006
ClinicalTrials.gov Identifier:	NCT00323921
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 14, 2009