RIPT of Ibuprofen Topical Gel

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Sodium chloride solution 0.9% (saline); Drug: Topical gel vehicle; Drug: Sodium lauryl sulfate 0.1%

• Registration Number: NCT01787448
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-05
• Study Start: 2013-01
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

Exclusion Criteria

Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sodium chloride solution 0.9% (saline)	Sodium chloride solution 0.9% (saline)	-
Ibuprofen 5% topical gel	Topical gel vehicle	-
Topical gel vehicle	Topical gel vehicle	-
Sodium lauryl sulfate 0.1%	Sodium lauryl sulfate 0.1%	-

Primary Outcome Measures

Name	Time	Method
Dermal sensitization potential	24-72 hours after last patch removal

Secondary Outcome Measures

Name	Time	Method
Cumulative Irritancy	48-72 hours after each patch application
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	During study through 28 days after last product application

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Carlstadt, New Jersey, United States