Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster

Summary

This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases: Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.

Timeline

Start

2018-08-09

Primary completion

2018-10-25

Completion

2018-10-25

Drugs

Indications

No indication recorded.