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

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ClinicalTrials.gov Identifier: NCT02460289
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Male Pattern of Hair Loss, Androgenic Alopecia Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 5% Foam and Botanical Hair Solution Regimen in Men With Thinning Hair and Male Pattern of Hair Loss/Androgenic Alopecia (Norwood III & IV)
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Experimental: Treatment Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men



Primary Outcome Measures :
  1. Investigator Global Photograph Rating [ Time Frame: 12 weeks ]
    Change in investigator global photograph rating from baseline


Secondary Outcome Measures :
  1. Subject Rating [ Time Frame: 12 weeks ]
    Change in subject rating from baseline

  2. Hair Wash/Shed Hair Count [ Time Frame: 12 weeks ]
    Change in shed hair count from baseline

  3. Subject Satisfaction Questionnaire [ Time Frame: 12 weeks ]
    The number and percent of subjects in each response category for each questionnaire administered at Week 4, Week 6 and Week 12.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 12 weeks ]
    Incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key 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).

Key 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.


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): NCT02460289


Locations
United States, Texas
Stephens & Associates
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Warren Winkelman, MD, PhD, MBA Galderma Laboratories, L.P.

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02460289     History of Changes
Other Study ID Numbers: GLI.04.SPR.US 10329
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents