Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finlândia Association + finasteride placebo
Minoxidil + finasteride
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring androgenetic alopecia
Eligibility Criteria
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 5α 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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FINLÂNDIA
Minoxidil + finasteride
Arm Description
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow: 1 tablet finasteride placebo, oral, once a day. 1 mL Finlândia hair lotion, topical, twice a day.
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow: 1 tablet finasteride, oral, once a day. 1 mL minoxidil hair lotion, topical, twice a day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04594018
Brief Title
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
androgenetic alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FINLÂNDIA
Arm Type
Experimental
Arm Description
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:
1 tablet finasteride placebo, oral, once a day.
1 mL Finlândia hair lotion, topical, twice a day.
Arm Title
Minoxidil + finasteride
Arm Type
Active Comparator
Arm Description
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:
1 tablet finasteride, oral, once a day.
1 mL minoxidil hair lotion, topical, twice a day.
Intervention Type
Drug
Intervention Name(s)
Finlândia Association + finasteride placebo
Intervention Description
Finlândia association hair lotion + finasteride placebo
Intervention Type
Drug
Intervention Name(s)
Minoxidil + finasteride
Intervention Description
Minoxidil hair lotion + Finasteride 1 mg
Primary Outcome Measure Information:
Title
Change from baseline in hair density.
Description
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 months
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 5α 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monalisa FB Oliveira, MD
Phone
+551938879851
Email
pesquisa.clinica@ncfarma.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
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