Minoxidil Response Testing in Males With Androgenetic Alopecia

Study Overview
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Brief Summary
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Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous. Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker. Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam. The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Official Title
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Minoxidil Response Testing in Males With Androgenetic Alopecia

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: 5% minoxidil topical foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males in overall good health Age: 18 to 49 Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale 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 Able to comply with the study requirements for 16 consecutive weeks Exclusion Criteria: Previous adverse event from topical minoxidil treatment Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride Does not use and have not used in the past 6 months minoxidil (topical or oral) Does not take 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Predicted as non-responders<br>Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group. | Drug: 5% minoxidil topical foam<br>* 5% minoxidil topical foam<br>* Other names: Regaine 5% minoxidil foam;|
| Predicted as responders<br>Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group. | Drug: 5% minoxidil topical foam<br>* 5% minoxidil topical foam<br>* Other names: Regaine 5% minoxidil foam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region |  | baseline to week 16 | 
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings |  | baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth |  | baseline to week 16 | 
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region |  | baseline to week 16 | 
| Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit |  | baseline to week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia, androgenetic alopecia, hair loss, minoxidil, 5% minoxidil foam, male pattern hair loss