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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04721548
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

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.




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®)



Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721548


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

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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents