The Efficacy Of The Wavelight Mydon Laser for Hair Removal And Treatment of Leg Veins

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00366964
First received: August 19, 2006
Last updated: August 11, 2009
Last verified: August 2009
  Purpose

This study is being done to compare the efficacy of an FDA cleared laser device with other similar systems in the market for the treatment of leg veins and hair removal in patients with darker skin type.


Condition Intervention
Leg Veins
Hair Removal
Device: Laser Treatment
Device: Wave Light laser device for skin treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determine The Efficacy Of The Wavelight Mydon Laser For Hair Removal And Treatment of Leg Veins

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Safety and efficacy of the treatment will determine the outcome. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Device Device: Laser Treatment
The laser treatment involves the use of an FDA approved laser device (510K Clearance certificate) for hair removal and treatment of leg veins for females having skin types III - VI. The pulses are of appropriate energy and pulse duration based on the skin type.
Device: Wave Light laser device for skin treatment
To determine efficacy of FDA approved Laser treatment for hair removal and leg veins. The Mydon Wavelight is a Long Pulsed Nd Yag Laser, Class IV 1064 nm 55W

Detailed Description:

The specific aim of the study is to determine the efficacy of this FDA approved laser for hair removal and treatment of leg veins in female patients having darker skin types (Fitzpatrick Skin type III-VI) and compare it with the efficacy of other similar commercial units available in the U.S.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female patients of Asian and darker skin type greater than or equal to 18 years of age.
  2. Ability to give informed consent.

Exclusion Criteria:

  1. Pregnancy.
  2. Taking medications that are photosensitizing.
  3. History of skin disease in the area to be treated over the last 6 months.
  4. Ongoing cutaneous lupus erythematosus, morphea, alopecia areata, or severe folliculitis.
  5. History of keloidal or hypertrophic scarring.
  6. Have inadequate hair growth in the test area of axilla.
  7. Have unrealistic expectations of the treatment.
  8. Co-existing severe emotional, medical or surgical illness leading to the inability to meet the follow-up requirements.
  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: NCT00366964

Locations
United States, California
University of California, Davis Medical Center Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Daniel B Eisen, M.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Daniel Eisen, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00366964     History of Changes
Other Study ID Numbers: 200412776-1
Study First Received: August 19, 2006
Last Updated: August 11, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 22, 2014