Back to results

Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

Primary Purpose

Androgenetic Alopecia

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LH80 PRO

Sham Device

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Axis Clinical Tirals
MedaPhase, Inc.
NW Dermatology & Research Center, LLC
Tennessee Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

LH80 PRO

Sham device

Arm Description

Low level laser therapy

No low level laser therapy

Outcomes

Primary Outcome Measures

Hair growth

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

Quantitative Hair Growth

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

Secondary Outcome Measures

Subject Self Assessment

Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.

Full Information

NCT ID

NCT02528552

First Posted

August 17, 2015

Last Updated

December 1, 2016

Sponsor

Theradome, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02528552

Brief Title

Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theradome, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Androgenetic Alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LH80 PRO

Arm Type

Active Comparator

Arm Description

Low level laser therapy

Arm Title

Sham device

Arm Type

Sham Comparator

Arm Description

No low level laser therapy

Intervention Type

Device

Intervention Name(s)

LH80 PRO

Intervention Type

Device

Intervention Name(s)

Sham Device

Primary Outcome Measure Information:

Title

Hair growth

Description

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

Time Frame

26 weeks

Title

Quantitative Hair Growth

Description

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

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Subject Self Assessment

Description

Determination of subject ability to self-assess hair loss and correctly use the device via direct observation and use of diary.

Time Frame

26 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Axis Clinical Tirals

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

MedaPhase, Inc.

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

NW Dermatology & Research Center, LLC

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Tennessee Clinical Research Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

We'll reach out to this number within 24 hrs