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NCT Number: NCT00366964

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Laser treatment

Device

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.

Wave Light laser device for skin treatment

Device

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

Primary outcomes

  1. Safety and efficacy of the treatment will determine the outcome.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Aug 22, 2006
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.