Behandeling van alopecia androgenetica bij mannen gedurende 24 weken (MINOX)
Een gerandomiseerde, dubbelblinde studie met parallelle groepen ter evaluatie van de werkzaamheid en veiligheid van een nieuwe farmaceutische vorm Minoxidil 5% voor de behandeling van alopecia androgenetica bij mannen gedurende 24 weken
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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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São Paulo
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São Paulo, São Paulo, Brazilië, 06696-000
- Eurofarma Laboratorios S.A
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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;
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Minoxidil´s Placebo
The recommended dosage is 1 ml of the solution twice a day (morning and evening). |
1 mL of solution twice a day. |
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Experimenteel: Topical Minoxidil 5%
The recommended dosage is 1 ml of the solution twice a day (morning and evening). |
Apply 1 mL of solution twice a day. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density.
Tijdsspanne: 24 weeks
|
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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EF171
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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