Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia

NCT ID: NCT02460289

Last Updated: 2023-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-19

Study Completion Date

2015-11-30

Brief Summary

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The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Detailed Description

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Conditions

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Male Pattern of Hair Loss, Androgenic Alopecia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Treatment: Minoxidil 5% / Botanical Hair Solution for Men

Intervention Type DRUG

Interventions

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Treatment: Minoxidil 5% / Botanical Hair Solution for Men

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male patients age 18 to 60 years at the time of enrollment.
2. Men who have self-perceived thinning hair.
3. Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Exclusion Criteria

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4\. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warren Winkelman, MD, PhD, MBA

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Stephens & Associates

Richardson, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GLI.04.SPR.US 10329

Identifier Type: -

Identifier Source: org_study_id

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