Ibuprofen 5% Topical Gel CIPT

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Topical gel vehicle; Drug: Ibuprofen 5% topical gel; Drug: Sodium lauryl sulfate 0.2%; Drug: Sodium chloride solution 0.9% (saline)

• Registration Number: NCT01771822
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-05
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Healthy male and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder

Exclusion Criteria

Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable 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
Topical gel vehicle	Topical gel vehicle	-
Ibuprofen 5% topical gel	Ibuprofen 5% topical gel	-
Sodium lauryl sulfate 0.2%	Sodium lauryl sulfate 0.2%	-
Sodium chloride solution 0.9% (saline)	Sodium chloride solution 0.9% (saline)	-

Primary Outcome Measures

Name	Time	Method
Assessment of local skin irritation at patch sites	Daily for 21 days, Days 2 through 22

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Days 1 through 22, + 28 days after last product administration

Trial Locations

Locations (1)

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