Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

Study Overview
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Brief Summary
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Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.

Detailed Description
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Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population. This disorder, although more visible in men, is suffered by both men and women. Recent studies show that the stress experienced by patients with alopecia can be similar or greater than that suffered by a more serious or chronic disease. For all these reasons, alopecia can prefer a social problem without a definitive therapeutic solution.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit. The lipid nature of the formulation and the droplet size of between 150-300 nm means that the emulsion drops easily penetrate the hair follicle and accumulate in the sebaceous glands of said follicles.

Official Title
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Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

Conditions
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Male Androgenetic Alopecia

Intervention / Treatment
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* Drug: Dutasteride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • - Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months. - Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form. - Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study. Exclusion Criteria: • - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors. - Patients with severe hepatic insufficiency. - Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months. - Patients unable to understand the objective of the study or to give informed consent. - Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study. - Patients with a history of drug addiction and drug addictions. - Patients who are participating in another clinical trial. - Patients whose partner is pregnant

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental drug<br>0.15% w/w dutasteride topical O/W emulsion. | Drug: Dutasteride<br>* The application will be made locally (spray for topical application on the scalp) Application: 1 mL (6 sprays) once a day. Each 1mL of formulation has approximately 1.5mg of Dutasteride (more precisely it would be 1.4835mg when considering density).<br>|
| Placebo Comparator: Placebo<br>vehicle (excipients) | Other: Placebo<br>* Vehicle excipient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Local adverse events (AEs) and systemic adverse reactions - Hair microbiome analysis | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy in hair loss reduction | Clinical improvement. Standardized photographs will be taken | 7 months |