Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-60
SponsorApsen Farmaceutica S.A.

About this trial

The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • APSMNF 1
  • APSMNF 2
  • Eniagor®

Treatment groups

336 Participants
are divided into 3 treatment groups

Sponsors and collaborators