RIPT of Ibuprofen Topical Gel

Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Topical gel vehicle; Drug: Sodium lauryl sulfate 0.1%; Drug: Sodium chloride solution 0.9% (saline)

• Study Type: Interventional
• Enrollment (Actual): 234
• 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: Yes
• Genders Eligible for Study: All

Description

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 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: Topical gel vehicle; 0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Experimental: Topical gel vehicle	Drug: Topical gel vehicle; 0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Sham Comparator: Sodium chloride solution 0.9% (saline)	Drug: Sodium chloride solution 0.9% (saline); 0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Active Comparator: Sodium lauryl sulfate 0.1%	Drug: Sodium lauryl sulfate 0.1%; 0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dermal sensitization potential	24-72 hours after last patch removal

Secondary Outcome Measures

Outcome Measure	Time Frame
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

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: February 6, 2013
• First Posted (Estimate): February 8, 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: repeat insult patch test
• Other Study ID Numbers: B3491007