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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental drug | Experimental | 0.15% w/w dutasteride topical O/W emulsion. |
|
| Placebo | Placebo Comparator | vehicle (excipients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Local adverse events (AEs) and systemic adverse reactions - Hair microbiome analysis | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in hair loss reduction | Clinical improvement. Standardized photographs will be taken | 7 months |
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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.
Exclusion Criteria:
• - Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors.
Male
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Muñoz, MD | IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
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Double blind placebo controlled
| Placebo | Other | Vehicle excipient |
|
| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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