- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594018
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
February 15, 2024 updated by: EMS
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.
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
190
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monalisa FB Oliveira, MD
- Phone Number: +551938879851
- Email: pesquisa.clinica@ncfarma.com.br
Study Locations
-
-
São Paulo
-
Osasco, São Paulo, Brazil
- Recruiting
- Medcin Instituto Da Pele
-
Contact:
- FLAVIA ADDOR
- Phone Number: 551136816362
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FINLÂNDIA
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. |
Finlândia association hair lotion + finasteride placebo
|
Active Comparator: Minoxidil + finasteride
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. |
Minoxidil hair lotion + Finasteride 1 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in hair density.
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events recorded during the study.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2023
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
October 14, 2020
First Submitted That Met QC Criteria
October 14, 2020
First Posted (Actual)
October 20, 2020
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Pathological Conditions, Anatomical
- Hypotrichosis
- Hair Diseases
- Alopecia
- Alopecia Areata
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- 5-alpha Reductase Inhibitors
- Finasteride
- Minoxidil
Other Study ID Numbers
- EMS2119 - FINLÂNDIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Androgenetic Alopecia
-
University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
-
Suzhou Kintor Pharmaceutical Inc,Completed
-
King Edward Medical UniversityCompletedCombination of SVF and PRP for Androgenetic AlopeciaPakistan
-
Chong Kun Dang PharmaceuticalRecruitingAndrogenetic AlopeciaKorea, Republic of
-
Services Hospital, LahoreActive, not recruitingAndrogenetic AlopeciaPakistan
-
Hope Medicine (Nanjing) Co., LtdCompleted
-
Indonesia UniversityActive, not recruitingAndrogenetic AlopeciaIndonesia
-
Cairo UniversityCompleted
-
University Hospitals Cleveland Medical CenterUniversity of California, San Francisco; Kaiser PermanenteCompleted
-
Biosplice Therapeutics, Inc.CompletedAndrogenetic AlopeciaTurkey
Clinical Trials on Finlândia Association + finasteride placebo
-
EMSWithdrawn
-
EMSNot yet recruitingAphthous StomatitisBrazil
-
EMSWithdrawn
-
EMSRecruitingBenign Prostatic Hyperplasia | Erectile DysfunctionBrazil
-
Polichem S.A.CompletedAlopecia, AndrogeneticBelgium, Germany, Hungary, Russian Federation, Spain
-
GlaxoSmithKlineCompletedAndrogenetic AlopeciaJapan, Argentina, Peru, Philippines, Taiwan, Mexico, Chile, Russian Federation, Thailand
-
EMSNot yet recruitingErectile Dysfunction | Premature Ejaculation
-
Elorac, Inc.Completed
-
EMSWithdrawnArterial Hypertension
-
Masaryk UniversitySt. Anne's University Hospital Brno, Czech RepublicNot yet recruitingAlzheimer Disease | Healthy Aging | Mild Cognitive Impairment | Memory Disorders in Old AgeCzechia