An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers

NCT02250859 Phase 1 COMPLETED

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

Details

Lead sponsor	Vyne Therapeutics Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2014-09
Completion	2015-01

Conditions

• Acne

Interventions

• FMX101, Minocycline 4% foam

Primary outcomes

• adverse events — 22-25 days
  AEs will be assessed starting from informed consent signature until end of study)
• irritation and local reaction — 16 days
  The application area will be examined for irritation and local reaction
• Change from baseline in vital signs — 22-25 days
  sitting BP, HR, RR, oral temperature
• Cmax — 16 days
  will be assessed after 1 and 16 days of dosing
• Tmax — 16 days
  will be assessed after 1 and 16 days of dosing
• AUCT — 16 days
  will be assessed after 1 and 16 days of dosing

Countries

Israel