MINOX: Treatment of Androgenetic Alopecia in Men for 24 Weeks

Sponsor

Eurofarma Laboratorios S.A. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04721548

Collaborator

(none)

354

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia	Drug: Minoxidil Topical Foam Drug: Placebo	Phase 3

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 study is to evaluate efficacy by assessing nonvellus target area hair count after using a new topical formulation of Minoxidil 5% compared to placebo applied topically for 24 weeks.

Among the secondary objectives, other aspects of effectiveness and safety will be evaluated, such as quality of life, vital signs, and other parameters.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. The primary objective of the study is to evaluate efficacy by assessing nonvellus target area hair count after using a new topical formulation of Minoxidil 5% compared to placebo applied topically for 24 weeks.Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. The primary objective of the study is to evaluate efficacy by assessing nonvellus target area hair count after using a new topical formulation of Minoxidil 5% compared to placebo applied topically for 24 weeks.

Masking:

Double (Participant, Investigator)

Masking Description:

Masking will be adopted in this study, in which the experimental products under evaluation will be provided in a masked way, that is, one group will receive an experimental drug (Minoxidil 5%) and another group will receive a placebo (product without the active ingredient) in identical primary and secondary packaging to avoid potential bias, so neither the researcher nor the research participant will know what is being applied.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Minoxidil´s Placebo The recommended dosage is 1 ml of the solution twice a day.	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.	Drug: Minoxidil Topical Foam 1 mL of solution twice a day.

Arm

Intervention/Treatment

Placebo Comparator: Minoxidil´s Placebo

The recommended dosage is 1 ml of the solution twice a day.

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.

Drug: Minoxidil Topical Foam

1 mL of solution twice a day.

Outcome Measures

Primary Outcome Measures

Mean variation by counting non-velus hair in the target region between baseline and week 24. [24 weeks]
Evaluation by phototrichogram (Trichoscan®)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 18 and 65 years;
Male pattern baldness identified according the Nowood scale: stage IIIv vertex, stage IV, or stage V;
Hair density equal or less than 220 hairs/ cm2 measured with TrichoScan;
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 ;
Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics.
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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eurofarma Laboratorios S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eurofarma Laboratorios S.A.

ClinicalTrials.gov Identifier:

NCT04721548

Other Study ID Numbers:

EF171

First Posted:

Jan 22, 2021

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alopecia

Alopecia Areata

Minoxidil

Study Results

No Results Posted as of Apr 15, 2022