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Treatment of male pattern baldness with topical Dutasteride

Topical Dutasteride in the Treatment of Male Pattern Alopecia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ygm86f
Enrollment
Unknown
Registered
2025-07-04
Start date
2024-04-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia

Interventions

This is a randomized, single-center, double-blinded trial with a 24-week longitudinal follow-up. A total of 30 patients who meet the eligibility criteria will be randomly divided into two groups of 15

Sponsors

Clinica Sanabria Transplante e Restauração Capilar
Lead Sponsor
Hospital Universitário Maria Aparecida Pedrossian da Universidade Federal do Mato Grosso do Sul
Collaborator

Eligibility

Sex/Gender
Male
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Males; Age between 20 and 60 years; Diagnosis of Androgenetic Alopecia grades 3V, 4V or 5V on the Norwood-Hamilton scale

Exclusion criteria

Exclusion criteria: Patients who have undergone hair loss treatment in the last 4 months; those with systemic arterial hypertension; heart disease; kidney disease; those with other causes of hair loss or scalp dermatoses

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: An increase in the density of terminal hairs in the target area is expected, greater in the group using dutasteride 0.2% compared to the group with 0.1%, assessed by comparing the trichoscopic photography performed before treatment and repeated after 24 weeks, in the vertex region using FotoFinder equipment and analysis and counting of the total number of hairs using Tricholab software, with long hair.

Secondary

MeasureTime frame
Expected outcome 2: An increase in the density of total hairs in the target area is expected, greater in the group using dutasteride 0.2% compared to the group with 0.1%, assessed by comparing the trichoscopic photography performed before treatment and repeated after 24 weeks, in the vertex region using FotoFinder equipment and analysis and counting of the total number of hairs using Tricholab software, with long hair.;Expected outcome 3: Overall hair coverage is expected to improve more in the dutasteride 0.2% group than in the dutasteride 0.1% group, as assessed by comparing standardized clinical photographs taken pre-treatment and after 24 weeks, with patients being asked to maintain the same hair style, color, length, and cut throughout the study. The standardized photographs were evaluated by 3 dermatologists who were blinded to treatment. Each dermatologist compared the baseline photograph with the photograph after 24 weeks of treatment and used a 7-point comparison scale: marked worsening (-3), moderate worsening (-2), slight worsening (-1), no change (0), slight improvement (+1), moderate improvement (+2), and marked improvement (+3).

Countries

Brazil

Contacts

Public ContactMarcelo Medeiros

Clinica Sanabria Transplante e Restauração Capilar

zanolli_marcelo@hotmail.com+55(67)981809696

Outcome results

None listed

Source: REBEC (via WHO ICTRP)