NCT02528552

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

August 17, 2015

Last Update Submit

December 1, 2016

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

  • Hair growth

    Determination of hair growth vs baseline through global photographic review by a blinded reviewer(s).

    26 weeks

  • Quantitative Hair Growth

    Change from baseline in non-vellus Terminal Hair count (≥ 30 μm) as measured with macrophotography (aka trichogram).

    26 weeks

Secondary Outcomes (1)

  • Subject Self Assessment

    26 weeks

Study Arms (2)

LH80 PRO

ACTIVE COMPARATOR

Low level laser therapy

Device: LH80 PRO

Sham device

SHAM COMPARATOR

No low level laser therapy

Device: Sham Device

Interventions

LH80 PRODEVICE
LH80 PRO
Sham DeviceDEVICE
Sham device

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Axis Clinical Tirals

Los Angeles, California, 90036, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

NW Dermatology & Research Center, LLC

Portland, Oregon, 97210, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-11

Locations

US(4)