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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Male Androgenetic Alopecia
• Intervention / Treatment: Drug: Dutasteride; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Estimated): April 29, 2024
• Study Completion (Estimated): April 29, 2024

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: ALOSTOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No