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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967277
• Other study ID #: USC650
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: May 5, 2015
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Capillus, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• Handi-Dome Laser
One, 30 minute treatment, every other day for 16 weeks.
• Incandescent red light source.
One, 30 minute treatment, every other day for 16 weeks.

Locations

Country	Name	City	State
United States	Bodian Dermatology	Great Neck	New York
United States	Center for Aesthetic Dermatology	Woodbury	New York

Sponsors (1)

Lead Sponsor	Collaborator
Capillus, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.	At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.	baseline and 17 weeks	No
Primary	Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.	At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.	baseline and 17 weeks	No