Ibuprofen 5% Topical Gel CIPT

Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ibuprofen 5% topical gel; Drug: Topical gel vehicle; Drug: Sodium lauryl sulfate 0.2%; Drug: Sodium chloride solution 0.9% (saline)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Carlstadt, New Jersey, United States, 07652
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen 5% topical gel	Drug: Ibuprofen 5% topical gel; 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
Experimental: Topical gel vehicle	Drug: Topical gel vehicle; 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
Active Comparator: Sodium lauryl sulfate 0.2%	Drug: Sodium lauryl sulfate 0.2%; 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
Sham Comparator: Sodium chloride solution 0.9% (saline)	Drug: Sodium chloride solution 0.9% (saline); 0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of local skin irritation at patch sites	Daily for 21 days, Days 2 through 22

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Estimate): February 28, 2013
• Last Update Submitted That Met QC Criteria: February 27, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: cumulative irritancy patch test (CIPT)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: B3491004