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

NCT03639571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-04-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Ibuprofen 200 mg TEPI Medicated Plaster

Ibuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK

OTHER

Placebo TEPI Plaster

Placebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK

Sponsors & Collaborators

  • Cooperative Clinical Drug Research and Development AG (CCDRD AG)

    collaborator OTHER

  • Medherant Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2018-10-25
Completion
2018-10-25

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639571 on ClinicalTrials.gov