Androgenetic Alopecia
Conditions
Interventions
This is a clinical trial in twenty male voluntary patients diagnosed with male androgenetic alopecia, to evaluate the effectiveness of botulinum toxin as a therapeutic option. The study will be self-c
10 points) in the first evaluation and after the 16th week. The contralateral region will receive 10 punctures of 0.9% saline solution on the same occasions. Clinical and trichoscopic photographs will
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Sponsors
Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro
Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro
Eligibility
Sex/Gender
Male
Age
20 Years to 35 Years
Inclusion criteria
Inclusion criteria: Male patients; androgenetic alopecia diagnosis; involvement of the vertex and frontotemporal recesses; age between 20 and 35 years; less than 5 years of disease evolution; all ethnicities and prototypes; patients who never used a treatment and patients who have not used medication for at least six months.
Exclusion criteria
Exclusion criteria: Individuals outside the age range defined for the research; evolution of disease greater than 5 years; women as this is a study aimed at a male audience. Patients with other inflammatory; patients with infectious or tumor conditions concomitant with androgenetic alopecia that affect the scalp and patients undergoing treatment for androgenetic alopecia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will verify whether there was an increase in hair density and/or thickness of hair in male patients with androgenetic alopecia who underwent injectable application of botulinum toxin in the bald region compared to those who received placebo. Thus, the effectiveness of botulinum toxin will be evaluated by the hair-to-hair matching technology TrichoLAB hair-to-hair matching technology to ensure comparison between images in the same location. Median comparisons will be made between one side of the vertex and the contralateral side in each of the three consultations and on each side over time, based on the parameters of total density, hair thickness and total new hairs, at the vertex and in the contralateral side. Wilcoxon's non-parametric test for paired samples will be used. The level of statistical significance adopted will be 5% Therefore, it will be possible to evaluate the improvement of their clinical condition and possible positive impact on the patient's self-esteem and quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactDaniel Melo
Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro
Outcome results
None listed