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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366964
Other study ID # 200412776-1
Secondary ID
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


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
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