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Phase I Methodology Study to Validate the Cantharidin Blister Model in Healthy Volunteers

NCT01762787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-06-28

No results posted yet for this study

Summary

The purpose of this study is to refine the cantharidin-induced blister assay in healthy volunteers as a model of inflammatory disease. The study is an experimental trial in healthy volunteers in two parts; Part 1 to optimise the model and Part 2 to validate using two anti-inflammatory treatments with different modes of action.

Conditions

Interventions

DRUG

Cantharidin solution

5 microlitres of 0.025 to 0.5% topically on Day 1, 2 and 3

DRUG

Aspirin

300mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only

DRUG

Prednisolone

30mg orally once a day over a course of 4 days (starting Day -3) Part 2 only

DRUG

Placebo to aspirin

0mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only

DRUG

Placebo to prednisolone

0mg orally once a day over a course of 4 days (starting Day -3) Part 2 only

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-17
Primary Completion
2011-01-14
Completion
2011-01-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01762787 on ClinicalTrials.gov