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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Leg Veins Hair Removal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Device

Group Type NO_INTERVENTION

Laser Treatment

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes