Alopecia, Androgenetic
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.
Interventions
DRUGAPSMNF 1
Administer twice a day during 24 weeks.
DRUGAPSMNF 2
Administer twice a day during 24 weeks.
DRUGEniagor®
Administer twice a day during 24 weeks.
Sponsors
Apsen Farmaceutica S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ; * Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period.
Exclusion criteria
* History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation; * Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years; * Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening; * Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in hair density assessed by phototrichogram. | Change from baseline after 24 weeks of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events incidence and classification | Through study completion, up to 24 weeks |
Countries
Brazil
Contacts
CONTACTBianca Zanetti
Outcome results
None listed