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

• ClinicalTrials.gov Identifier: NCT01967277
• Recruitment Status: Completed
• First Posted: October 22, 2013
• Results First Posted: May 6, 2015
• Last Update Posted: May 6, 2015
• Sponsor: Capillus, LLC
• Information provided by (Responsible Party): Capillus, LLC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Device: Handi-Dome Laser; Device: Incandescent red light source.	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
• Study Start Date: March 2014
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: September 2014

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Device: Incandescent red light source.; One, 30 minute treatment, every other day for 16 weeks.
Active Comparator: Handi-Dome Laser; Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.	Device: Handi-Dome Laser; One, 30 minute treatment, every other day for 16 weeks.

Outcome Measures

Primary Outcome Measures :

1. Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. [ Time Frame: baseline and 17 weeks ]
   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.
2. Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. [ Time Frame: baseline and 17 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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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Contacts and Locations

Locations

United States, New York

Bodian Dermatology

Great Neck, New York, United States, 11021

Center for Aesthetic Dermatology

Woodbury, New York, United States, 11797

Sponsors and Collaborators

Capillus, LLC

Investigators

• Study Director: Raymond R. Blanche, BA; NST Consulting, LLC

More Information

• Responsible Party: Capillus, LLC
• ClinicalTrials.gov Identifier: NCT01967277
• Other Study ID Numbers: USC650
• First Posted: October 22, 2013
• Results First Posted: May 6, 2015
• Last Update Posted: May 6, 2015
• Last Verified: May 2015

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical