Last reviewed · How we verify
A Prospective, Single Center, Randomized, Double-blind, Placebo Controlled Study in Two Phases to Evaluate the Safety and Efficacy of ATx201 as a Topical Antibiotic Agent
AntibioTx is developping ATx201 as a topical product for treatment of skin infections, including infected atopic dermatitis.
Details
| Lead sponsor | UNION therapeutics |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 73 |
| Start date | 2016-12 |
| Completion | 2018-03 |
Conditions
- Infection, Bacterial
Interventions
- ATx201 dermal formulations 2%
Primary outcomes
- Safety and tolerability of new topical formulations of ATx201 — 7 days
Number of subjects with treatment related adverse events. AEs will be classified into standardised terminology from the verbatim description (Investigator term) according to the MedDRA Coding Dictionary. AEs will be classified by MedDRA term and associated system organ class. The number and percentage of subjects reporting AEs will be summarised by treatment group, system organ class, MedDRA term, and Phase.
Countries
Austria