Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

Androgenetic Alopecia Clinical Trial

Official title:

A Multi-center, Randomized, Controlled, Double-blind Study That Evaluates a Low Level Laser Therapy Over-the-counter at Home Device, Theradome™ LH80 PRO vs a Sham Device, for Promoting Hair Growth in Males Diagnosed With Androgenetic Alopecia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02528552
• Other study ID #: CR-PRC-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 17, 2015
• Last updated: December 1, 2016
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: Theradome, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject must be diagnosed with androgenetic alopecia with Norwood Hamilton hair loss scale of IIa, III vertex, IV and V.

• Subject must have Fitzpatrick skin type scale I to IV.

• Subject must be able to visit clinic site for baseline, 13 week and 26 week study visits and attend 2 visits by phone ( 6 and 19).

• Hair must be at least 1 inch in length. The hairstyle and length shall be the same for each site visit. Subjects are instructed to have their hair cut/styled 1-5 days in advance of a site visit.

• Be willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding area of the vertex.

• Be willing to avoid use of wigs, hairpieces, and/or hair extensions during the study period.

• Ability to communicate effectively with study personnel.

• Agrees to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study

Exclusion Criteria:

• History of taking Propecia or any other hair growth supplements for 12 months prior to enrollment.

• History of using Rogaine for 6 months prior to enrollment.

• Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.

• Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata.

• Currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc).

• Subject has a sensitivity or allergy to tattoo ink.

• Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.

• Employed by sponsor, clinic site, or entity associated with the conduct of the study.

Study Design

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• LH80 PRO

• Sham Device

Locations

Country	Name	City	State
United States	Axis Clinical Tirals	Los Angeles	California
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	MedaPhase, Inc.	Newnan	Georgia
United States	NW Dermatology & Research Center, LLC	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Theradome, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair growth	Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).	26 weeks	No
Primary	Quantitative Hair Growth	Change from baseline in non-vellus Terminal Hair count (= 30 µm) as measured with macrophotography (aka trichogram).	26 weeks	No
Secondary	Subject Self Assessment	Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.	26 weeks	No