RIPT of Ibuprofen Topical Gel

Pfizer234 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

234

Conditions

Pain

Interventions

Topical gel vehicleDRUG

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 vehicleDRUG

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%DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Carlstadt, New Jersey, United States

Outcomes

Primary Outcomes

Dermal sensitization potential

Time frame: 24-72 hours after last patch removal

Secondary Outcomes

Cumulative Irritancy

Time frame: 48-72 hours after each patch application

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: During study through 28 days after last product application

Data from ClinicalTrials.gov

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