A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.

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Detailed Description

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The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Incandescent red light source

A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Group Type PLACEBO_COMPARATOR

Incandescent red light source.

Intervention Type DEVICE

One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Group Type ACTIVE_COMPARATOR

Handi-Dome Laser

Intervention Type DEVICE

One, 30 minute treatment, every other day for 16 weeks.

Interventions

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Handi-Dome Laser

One, 30 minute treatment, every other day for 16 weeks.

Intervention Type DEVICE

Incandescent red light source.

One, 30 minute treatment, every other day for 16 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -

Exclusion Criteria

Photosensitivity to the specific wavelength of light - 650 nanometers. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp.

In willingness to remove hair replacement products during the 16 weeks of therapy.

Using any medications deemed to inhibit hair growth as determined by the physician investigator.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes