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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • APSMNF 1

    Drug

    Administer twice a day during 24 weeks.

  • APSMNF 2

    Drug

    Administer twice a day during 24 weeks.

  • Eniagor®

    Drug

    Administer twice a day during 24 weeks.

Treatment groups

336 Participants
are divided into 3 treatment groups
Group A: APSMNF 1Experimental treatment 1 intervention
Group B: APSMNF 2Experimental treatment 1 intervention
Group C: Eniagor®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Variation in hair density assessed by phototrichogram.

Time frame
Change from baseline after 24 weeks of treatment.

Secondary outcomes

1

Adverse events incidence and classification

Time frame
Through study completion, up to 24 weeks

Other outcomes

Sponsors and contacts

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