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

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: NCT00323921
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Candela Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Aged Skin Device: dermatological infrared laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : August 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007



Primary Outcome Measures :
  1. score on a grading scale at post treatment visits


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323921


Sponsors and Collaborators
Candela Corporation
Investigators
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Principal Investigator: E. V. Ross, M.D. United States Naval Medical Center, San Diego
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Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT00323921    
Other Study ID Numbers: 052603
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Dermatologic Agents