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

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05599243
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Male Androgenetic Alopecia	Drug: Dutasteride; Other: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double blind placebo controlled
• Primary Purpose: Treatment
• Official Title: Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
• Actual Study Start Date: Sep 29, 2022
• Anticipated Primary Completion Date: Apr 29, 2024
• Anticipated Study Completion Date: Apr 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental drug 0.15% w/w dutasteride topical O/W emulsion.	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).
Placebo Comparator: Placebo vehicle (excipients)	Other: Placebo; Vehicle excipient

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability [7 months]

   Local adverse events (AEs) and systemic adverse reactions - Hair microbiome analysis

Secondary Outcome Measures

1. Efficacy in hair loss reduction [7 months]

   Clinical improvement. Standardized photographs will be taken

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Ramón y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• ClinicalTrials.gov Identifier: NCT05599243
• Other Study ID Numbers: ALOSTOP
• First Posted: Oct 31, 2022
• Last Update Posted: Oct 31, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Dutasteride

Study Results

No Results Posted as of Oct 31, 2022