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

• ClinicalTrials.gov Identifier: NCT04721548
• Recruitment Status: Not yet recruiting
• First Posted: January 22, 2021
• Last Update Posted: April 15, 2022
• Sponsor: Eurofarma Laboratorios S.A.
• Information provided by (Responsible Party): Eurofarma Laboratorios S.A.

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 (Clinical Trial)
• Estimated 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.
• 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
• Estimated Study Start Date: August 30, 2022
• Estimated Primary Completion Date: July 30, 2023
• Estimated Study Completion Date: July 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts

Contact: Edilene Macedo; +55 11 5090-8422; edilene.macedo@eurofarma.com

Sponsors and Collaborators

Eurofarma Laboratorios S.A.

More Information

• Responsible Party: Eurofarma Laboratorios S.A.
• ClinicalTrials.gov Identifier: NCT04721548
• Other Study ID Numbers: EF171
• First Posted: January 22, 2021
• Last Update Posted: April 15, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Minoxidil; Antihypertensive Agents; Vasodilator Agents