Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster
Status:
Completed
Trial end date:
2018-10-25
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Medherant Ltd
Collaborator:
Cooperative Clinical Drug Research and Development AG (CCDRD AG)