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Ibuprofen 5% Topical Gel CIPT

NCT01771822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-02-28

No results posted yet for this study

Summary

This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.

Conditions

Interventions

DRUG

Ibuprofen 5% topical gel

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

DRUG

Topical gel vehicle

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

DRUG

Sodium lauryl sulfate 0.2%

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

DRUG

Sodium chloride solution 0.9% (saline)

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

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 NCT01771822 on ClinicalTrials.gov