Ibuprofen 5% Topical Gel CIPT

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771822
• Other study ID #: B3491004
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2012
• Last updated: February 27, 2013
• Start date: January 2013
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ibuprofen 5% topical gel
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
• Topical gel vehicle
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
• Sodium lauryl sulfate 0.2%
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
• Sodium chloride solution 0.9% (saline)
0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Carlstadt	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of local skin irritation at patch sites		Daily for 21 days, Days 2 through 22	Yes
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Days 1 through 22, + 28 days after last product administration	Yes

External Links

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