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

University of California, Davis10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Leg Veins Hair Removal

Interventions

Laser TreatmentDEVICE

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 treatmentDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

Safety and efficacy of the treatment will determine the outcome.

Time frame: 6 months

Data from ClinicalTrials.gov

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