Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
ConditionAndrogenetic Alopecia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-60
SponsorEMS
About this trial
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.
Disqualifiers
Known hypersensitivity to the formula components used during the clinical trial;
History of alcohol and/or substance abuse within 2 years;
Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;
Participants with a history of surgical treatment for hair loss or shaved scalp;
Trial design
Design model
Parallel
Treatments tested in this trial
Finlândia Association + finasteride placebo
DrugFinlândia association hair lotion + finasteride placebo
Minoxidil + finasteride
DrugMinoxidil hair lotion + Finasteride 1 mg
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: FINLÂNDIAExperimental treatment 1 intervention
Group B: Minoxidil + finasterideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in hair density.
Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.
Time frame
6 monthsSecondary outcomes
1
Incidence and severity of adverse events recorded during the study.
Time frame
6 months Source ClinicalTrials.gov