Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04594018
• Other study ID #: EMS2119 - FINLÂNDIA
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa FB Oliveira, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;
• Participants who used 5a reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;
• Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;
• Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;
• Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;
• Participants with diseases that can affect hair growth;
• Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• Finlândia Association + finasteride placebo
Finlândia association hair lotion + finasteride placebo
• Minoxidil + finasteride
Minoxidil hair lotion + Finasteride 1 mg

Locations

Country	Name	City	State
Brazil	Medcin Instituto Da Pele	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Incidence and severity of adverse events recorded during the study.		6 months