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Ibuprofen 5% Topical Gel CIPT

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: December 5, 2012
Last updated: February 27, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Drug: Ibuprofen 5% topical gel
Drug: Topical gel vehicle
Drug: Sodium lauryl sulfate 0.2%
Drug: Sodium chloride solution 0.9% (saline)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of local skin irritation at patch sites [ Time Frame: Daily for 21 days, Days 2 through 22 ]

Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Days 1 through 22, + 28 days after last product administration ]

Enrollment: 50
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01771822

United States, New Jersey
Pfizer Investigational Site
Carlstadt, New Jersey, United States, 07652
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01771822     History of Changes
Other Study ID Numbers: B3491004
Study First Received: December 5, 2012
Last Updated: February 27, 2013

Keywords provided by Pfizer:
cumulative irritancy patch test (CIPT)

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017