Treatment of Androgenetic Alopecia in Men for 24 Weeks (MINOX)

A Randomized, Double Blind, Parallel-group Study to Evaluate the Efficacy and Safety of a New Pharmaceutical Form Minoxidil 5% for the Treatment of Androgenetic Alopecia in Men for 24 Weeks

A prospective, randomized, double-blind, single-center, placebo-Controlled, parallel-group study to evaluate the efficacy and safety of a new pharmaceutical form Minoxidil 5% in men after 24 weeks of treatment.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia
• Intervention / Treatment: Drug: Placebo; Drug: Minoxidil Topical Foam

Detailed Description

Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. Through this method, it is possible to obtain more information about the effectiveness of investigational product.

The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days.

Secondary objectives: 1- To evaluate the efficacy of a new topical 5% minoxidil pharmaceutical form in the treatment of men with androgenetic alopecia, compared to placebo, by means of terminal strand density in the target area, evaluated 30 (±3), 60(±3), 90(±3) and 135(±3) days after the beginning of treatment.

2- To evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the percentage of anagen strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.

3- Evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the average length of hair strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Edilene Macedo, Analyst; Phone Number: +55 11 5090-8422; Email: edilene.macedo@eurofarma.com
• Study Contact Backup: Name: Natalia Gianni, Analyst; Phone Number: 41449500; Email: natalia.gianni@eurofarma.com

Study Locations

• Brazil
  • São Paulo, Brazil, 06696-000
    • Eurofarma Laboratorios S.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 65 years;
• Male pattern baldness identified according the Norwood Hamilton scale: stage IIIv vertex, stage IV, or stage V;
• Terminal hair density equal to or less than 220 hairs/cm2 measured with the Trichoscale Al;
• Subjects who are willing and able to comply with all requirements of the study for the intended period;
• Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document has been informed of all pertinent aspects of the trial;

Exclusion Criteria:

• Current or 6 months dated back use of:
• Minoxidil, finasteride, or any 5 alpha-reductase inhibitor;
• Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics
• Medications with anti-androgenic properties, such as: cyproterone, spironolactone, ketoconazole, flutamide, bicalutamide.
• Any anabolic steroid ;
• Current or 8 weeks dated back use of herbal products such as saw palmetto;
• Isotretinoin for at least 12 months;
• Current or 2 weeks dated back use of dietary or vitamin supplements;
• Subjects who had a dignosis of malignant disease in the alopecia area in the period of 05 years;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Minoxidil´s Placebo; The recommended dosage is 1 ml of the solution twice a day (morning and evening).	Drug: Placebo; 1 mL of solution twice a day.
Experimental: Topical Minoxidil 5%; The recommended dosage is 1 ml of the solution twice a day (morning and evening).	Drug: Minoxidil Topical Foam; Apply 1 mL of solution twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density.	The density of terminal hairs will be evaluated by phototrichogram (FotoFinder leviacam® and Trichoscale Al® Dermatoscope), with the baseline density resulting from the images captured on the VR and VR+2 days visits and the final density resulting from the images captured on the V5 and V5+2 days visits. Terminal wires will be classified as those with diameter greater than or equal to 30 um.	24 weeks

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: EF171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No