Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

• ClinicalTrials.gov Identifier: NCT02528552
• Recruitment Status: Unknown
• First Posted: August 19, 2015
• Last Update Posted: December 2, 2016
• Sponsor: Theradome, Inc.
• Information provided by (Responsible Party): Theradome, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Androgenetic Alopecia	Device: LH80 PRO; Device: Sham Device	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: August 2015
• Actual Primary Completion Date: October 2016
• Estimated Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: LH80 PRO; Low level laser therapy	Device: LH80 PRO
Sham Comparator: Sham device; No low level laser therapy	Device: Sham Device

Outcome Measures

Primary Outcome Measures :

1. Hair growth [ Time Frame: 26 weeks ]
   Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).
2. Quantitative Hair Growth [ Time Frame: 26 weeks ]
   Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).

Secondary Outcome Measures :

1. Subject Self Assessment [ Time Frame: 26 weeks ]
   Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

Axis Clinical Tirals

Los Angeles, California, United States, 90036

United States, Georgia

MedaPhase, Inc.

Newnan, Georgia, United States, 30263

United States, Oregon

NW Dermatology & Research Center, LLC

Portland, Oregon, United States, 97210

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

Sponsors and Collaborators

Theradome, Inc.

More Information

• Responsible Party: Theradome, Inc.
• ClinicalTrials.gov Identifier: NCT02528552
• Other Study ID Numbers: CR-PRC-001
• First Posted: August 19, 2015
• Last Update Posted: December 2, 2016
• Last Verified: November 2016

Additional relevant MeSH terms:

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