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

NCT05599243 | Completed Phase 2

• 1 other identifier: ALOSTOP
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Male Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  7 months

Secondary Outcomes (1)

• Efficacy in hair loss reduction

  7 months

Study Arms (2)

experimental drug

EXPERIMENTAL

0.15% w/w dutasteride topical O/W emulsion.

Drug: Dutasteride

Placebo

PLACEBO COMPARATOR

vehicle (excipients)

Other: Placebo

Interventions

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).

experimental drug

Placebo OTHER

Vehicle excipient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• - 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.

You may not qualify if:

• - 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Interventions

Dutasteride

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Oscar Muñoz, MD

  IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 31, 2022
• Study Start: September 29, 2022
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)