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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status and phase: Completed; Phase 2

Conditions: Male Androgenetic Alopecia

Treatments: Other: Placebo; Drug: Dutasteride

Study type: Interventional

Funder types: Other

Identifiers

NCT05599243

ALOSTOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

experimental drug

Experimental group

Description:

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

Treatment:

Drug: Dutasteride

Placebo

Placebo Comparator group

Description:

vehicle (excipients)

Treatment:

Other: Placebo