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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Candela Corporation
ClinicalTrials.gov Identifier:
NCT00323921
First received: May 9, 2006
Last updated: August 2, 2012
Last verified: August 2012
  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: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

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

Sponsors and Collaborators
Candela Corporation
Investigators
Principal Investigator: E. V. Ross, M.D. United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: Candela Corporation
ClinicalTrials.gov Identifier: NCT00323921     History of Changes
Other Study ID Numbers: 052603
Study First Received: May 9, 2006
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014