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Ibuprofen 5% Topical Gel CIPT

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ClinicalTrials.gov Identifier: NCT01771822
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain 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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
Study Start Date : January 2013
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


Information from the National Library of Medicine

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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771822


Locations
United States, New Jersey
Pfizer Investigational Site
Carlstadt, New Jersey, United States, 07652
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01771822     History of Changes
Other Study ID Numbers: B3491004
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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