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

Study Overview
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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).

Official Title
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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)

Conditions
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Male Pattern of Hair Loss, Androgenic Alopecia

Intervention / Treatment
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* Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male patients age 18 to 60 years at the time of enrollment. Men who have self-perceived thinning hair. Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III & IV). Key Exclusion Criteria: History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 | The Investigator or a trained grader rated each participant's standardized global photographs for improvement from baseline for parameters like hair thinning, hair growth, impression of scalp hair coverage and overall perception of treatment benefit using a 1-to-7-point Likert scale. Investigator global photograph rating were assessed using 7-point Likert scale. Each score on the individual scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree. | At Week 12 | 
| Change From Baseline in Participant Rating at Week 12 | Participants rated the parameters like appearance of hair, growth of hair, satisfaction with hairline at the front of the head, satisfaction with hair on the top of the head and satisfaction with hair overall as an overall improvement from the baseline by conducting their own assessments by looking in a mirror and evaluating improvement from baseline using a 1 to 7-point Likert scale. Each score on the individual scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree. | At Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Shed Hair Count | Participants collected their hair full day, including after combing and hair-washing. Participants turned in these hair collections at each visit. The results were averaged weekly. Mean change from baseline in hair wash/shed hair count was reported at Week 12. | At Week 12 | 
| Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Participant's satisfaction questionnaire was used to specifically collect the participants' feedback on the treatment regimen, the level of satisfaction and future usage. Participants were asked to complete a cosmetic acceptability questionnaire. This 10 item questionnaire had a 5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree). | At Week 4,6 and 12 |