Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02250859
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2014-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of Minocycline in Male and Female Volunteers
Sponsor:
Vyne Therapeutics Inc.
Organization:
Study Overview
Official Title:
An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers
Status:
COMPLETED
Status Verified Date:
2021-02
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:
None
Brief Summary:
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne
Detailed Description:
This is an open-label, single-center, non-randomized, multiple-administrations study in males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline (4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his eligibility to participate in the study, including a dermatological assessment of the acne severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety Follow-up visit will take place on 7-10 days after last dose, which will also include a dermatological assessment of response to treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: