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Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02528552
Recruitment Status : Unknown
Verified November 2016 by Theradome, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
Theradome, Inc.

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

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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

Resource links provided by the National Library of Medicine

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

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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528552

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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.
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Responsible Party: Theradome, Inc.
ClinicalTrials.gov Identifier: NCT02528552    
Other Study ID Numbers: CR-PRC-001
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical