male androgenetic alopecia
Conditions
Interventions
After signing the consent form, patients will be randomized (1: 1) into two groups: oral minoxidil 5 mg daily (Loniten® tablet fractionated in capsule 5mg) and placebo topical solution for use 2x dail
minoxidil 5% solution (Pant®) 1ml twice a day and oral placebo tablet once daily.
There will be a computerized randomization performed by an individual not involved in patient recruitment and follow-u
and ingest the placebo capsule at bedtime.
There will be 2 visits (initial and after 24 weeks) for counting and comparing the terminal and total scalp hairs before and after treatment, in each group.
Drug
D26.660
Sponsors
Universidade Estadual Paulista Julio de Mesquita Filho
Universidade Estadual Paulista Julio de Mesquita Filho
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: We will select ninety male patients aged between 18 and 55 years with the diagnosis of male androgenic alopecia, classified in the Norwood Hamilton scale as 3V, 4V or 5V, informed and agreeing to participate in the research. The diagnosis of male androgenic alopecia will be based on clinical, dermoscopic and histopathological criteria.
Exclusion criteria
Exclusion criteria: Patients who have had previous hair loss treatment in the last 6 months, hypertensive patients, heart disease, nephropaths, other causes of hair loss or scalp dermatosis will not be eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Density variation of treminal hairs of target area: tricoscopics photos will be performed in the vertex region using Heine Delta 20 equipment and Nikon D80 camera. With the ImageJ® software will be performed total count and evaluation of the average thickness of the region before the beginning of treatment and after 24 weeks. Hairs with a thickness greater than 0.04 mm will be considered terminal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total hair density variation in the target area: tricoscopics photos will be performed in the vertex region using Heine Delta 20 equipment and Nikon D80 camera. With the ImageJ® software will be performed total hairs count of the region before the beginning of treatment and after 24 weeks. ;Evaluation of sstandardized clinical photography: patients will be required to maintain the same style, color, length and haircut during the study. The standardized photos will be evaluated by 3 dermatologists blinded to treatment. Each dermatologist will compare the initial picture to the 24-week picture and use a 7-point comparison scale: major worsening (-3), moderate worsening (-2), slight worsening (-1), no change (0), slight improvement ( +1), moderate improvement (+2) and large improvement (+3). | — |
Countries
Brazil
Contacts
Public ContactMariana Penha
Universidade Estadual Paulista Julio de Mesquita Filho
Outcome results
None listed