NCT05599243

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Male Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Dutasteride	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).
OTHER	Placebo	Vehicle excipient

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2022-10-31
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain