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Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

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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
Sponsor:
Information provided by (Responsible Party):
Theradome, Inc.

Tracking Information
First Submitted Date  ICMJE August 17, 2015
First Posted Date  ICMJE August 19, 2015
Last Update Posted Date December 2, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • Hair growth [ Time Frame: 26 weeks ]
    Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).
  • Quantitative Hair Growth [ Time Frame: 26 weeks ]
    Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
  • Hair growth [ Time Frame: 26 weeks ]
    Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).
  • Quantiative Hair Growth [ Time Frame: 26 weeks ]
    Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Device: LH80 PRO
  • Device: Sham Device
Study Arms  ICMJE
  • Active Comparator: LH80 PRO
    Low level laser therapy
    Intervention: Device: LH80 PRO
  • Sham Comparator: Sham device
    No low level laser therapy
    Intervention: Device: Sham Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02528552
Other Study ID Numbers  ICMJE CR-PRC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Theradome, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Theradome, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Theradome, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP