RIPT of Ibuprofen Topical Gel

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787448
• Other study ID #: B3491007
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• 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 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 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:
• 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
• 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
• 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
• 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

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	Dermal sensitization potential		24-72 hours after last patch removal	Yes
Secondary	Cumulative Irritancy		48-72 hours after each patch application	Yes
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		During study through 28 days after last product application	Yes

External Links

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