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

Hair Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366964
• Other study ID #: 200412776-1
• Status: Completed
• Phase: N/A
• First received: August 19, 2006
• Last updated: April 6, 2015
• Start date: October 2004
• Est. completion date: April 2006

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hair Removal
• Leg Veins

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of the treatment will determine the outcome.		6 months	Yes

External Links

•   University of California-Davis Department of Dermatology Clinical Research