Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

Study Overview
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Brief Summary
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5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair. The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Detailed Description
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Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil. 5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair. Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events. Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Official Title
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Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

Conditions
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Female Pattern Hair Loss, Androgenetic Alopecia

Intervention / Treatment
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* Drug: 5% Topical Minoxidil Solution
* Drug: 15% Topical Minoxidil Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in overall good health Age: 18 to 55 Female pattern hair loss (Sinclair 2-4) Willing to have a mini dot tattoo placed in the target area of the scalp Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study Able to give informed consent Non-responder to 5% minoxidil as determined by the MX-IVD test i.e., low minoxidil metabolizer Able to comply with the study requirements for 24 consecutive weeks Willing to use an adequate method of birth control (if applicable) Negative urine pregnancy test Exclusion Criteria: Previous adverse event from topical minoxidil treatment History of hypotension Uncontrolled hypertension Use of any hypertensive drugs Pregnant, nursing, or planning a pregnancy during the study Prior hair transplant Uses wigs or hair weaves Have used minoxidil (topical or oral) anytime during the past 6 months Chronic scalp disorders that require medications Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics Folliculitis Scalp psoriasis Seborrheic dermatitis Inflammatory scalp conditions such as lichen planopilaris Enrolled in any other medical study or has been enrolled in any medical study in the past 30 days Responder to 5% minoxidil as determined by the MX-IVD test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 5% Topical Minoxidil Solution<br>5% Topical Minoxidil Solution | Drug: 5% Topical Minoxidil Solution<br>* 5% Topical Minoxidil Solution<br>|
| Active Comparator: 15% Topical Minoxidil Solution<br>15% Topical Minoxidil Solution | Drug: 15% Topical Minoxidil Solution<br>* 15% Topical Minoxidil Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Area Hair Count | Target Area Hair Count. Number of hairs measured in the target area by macrophotography | baseline to week 24 | 
| Subjects Ratings | Subjects Ratings | baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Area Hair Count | Target Area Hair Count. Number of hairs measured in the target area by macrophotography. | baseline to week 12 | 
| Expert Panel Global Photography Assessment | Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth | baseline to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hairloss, Female Pattern Hair Loss, Androgenetic Alopecia, Minoxidil