Treatment of Androgenetic Alopecia in Men for 24 Weeks

Study Overview
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Brief Summary
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A prospective, randomized, double-blind, single-center, placebo-Controlled, parallel-group study to evaluate the efficacy and safety of a new pharmaceutical form Minoxidil 5% in men after 24 weeks of treatment. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Detailed Description
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Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. Through this method, it is possible to obtain more information about the effectiveness of investigational product. The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days. Secondary objectives: 1- To evaluate the efficacy of a new topical 5% minoxidil pharmaceutical form in the treatment of men with androgenetic alopecia, compared to placebo, by means of terminal strand density in the target area, evaluated 30 (±3), 60(±3), 90(±3) and 135(±3) days after the beginning of treatment. 2- To evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the percentage of anagen strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment. 3- Evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the average length of hair strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Official Title
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A Randomized, Double Blind, Parallel-group Study to Evaluate the Efficacy and Safety of a New Pharmaceutical Form Minoxidil 5% for the Treatment of Androgenetic Alopecia in Men for 24 Weeks

Conditions
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Alopecia

Intervention / Treatment
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* Drug: Minoxidil Topical Foam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years; Male pattern baldness identified according the Norwood Hamilton scale: stage IIIv vertex, stage IV, or stage V; Terminal hair density equal to or less than 220 hairs/cm2 measured with the Trichoscale Al; Subjects who are willing and able to comply with all requirements of the study for the intended period; Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document has been informed of all pertinent aspects of the trial; Exclusion Criteria: Current or 6 months dated back use of: Minoxidil, finasteride, or any 5 alpha-reductase inhibitor; Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics Medications with anti-androgenic properties, such as: cyproterone, spironolactone, ketoconazole, flutamide, bicalutamide. Any anabolic steroid ; Current or 8 weeks dated back use of herbal products such as saw palmetto; Isotretinoin for at least 12 months; Current or 2 weeks dated back use of dietary or vitamin supplements; Subjects who had a dignosis of malignant disease in the alopecia area in the period of 05 years;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Minoxidil´s Placebo<br>The recommended dosage is 1 ml of the solution twice a day (morning and evening). | Drug: Placebo<br>* 1 mL of solution twice a day.<br>|
| Experimental: Topical Minoxidil 5%<br>The recommended dosage is 1 ml of the solution twice a day (morning and evening). | Drug: Minoxidil Topical Foam<br>* Apply 1 mL of solution twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density. | The density of terminal hairs will be evaluated by phototrichogram (FotoFinder leviacam® and Trichoscale Al® Dermatoscope), with the baseline density resulting from the images captured on the VR and VR+2 days visits and the final density resulting from the images captured on the V5 and V5+2 days visits. Terminal wires will be classified as those with diameter greater than or equal to 30 um. | 24 weeks |