Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721548
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-01-14
Brief Title:
Treatment of Androgenetic Alopecia in Men for 24 Weeks
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINOX
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
Study will only be conducted in research centers in Brazil please do not send e-mail if your center is outside brazil
Study will only be conducted in research centers in Brazil please do not send e-mail if your center is outside brazil
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 3 603 903 and 1353 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 303 603 903 1353 and 1803 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 303 603 903 1353 and 1803 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
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 3 603 903 and 1353 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 303 603 903 1353 and 1803 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 303 603 903 1353 and 1803 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None