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

Capillus

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Device: Incandescent red light source.; Device: Handi-Dome Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967277

USC650

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Incandescent red light source

Placebo Comparator group

Description:

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

Treatment:

Device: Incandescent red light source.

Handi-Dome Laser

Active Comparator group

Description:

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

Treatment:

Device: Handi-Dome Laser