Clinical trial NCT05599243: Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
Official title: Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Male Androgenetic Alopecia
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 7 months
Secondary outcomes:
measure: Efficacy in hair loss reduction
timeFrame: 7 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
name: Oscar Muñoz, MD
role: PRINCIPAL_INVESTIGATOR
References: