Ibuprofen 5% Topical Gel CIPT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01771822
First received: December 5, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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
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
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01771822     History of Changes
Other Study ID Numbers: B3491004
Study First Received: December 5, 2012
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014