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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323921
First Posted: May 10, 2006
Last Update Posted: August 3, 2012
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.
Information provided by (Responsible Party):
Candela Corporation
  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

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Candela Corporation:

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

Enrollment: 36
Study Start Date: August 2005
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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

  Contacts and Locations
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
Principal Investigator: E. V. Ross, M.D. United States Naval Medical Center, San Diego
  More Information

Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT00323921     History of Changes
Other Study ID Numbers: 052603
First Submitted: May 9, 2006
First Posted: May 10, 2006
Last Update Posted: August 3, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Dermatologic Agents