Ibuprofen 5% Topical Gel CIPT

Pfizer50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Ibuprofen 5% topical gelDRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Topical gel vehicleDRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Sodium lauryl sulfate 0.2%DRUG

0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Carlstadt, New Jersey, United States

Outcomes

Primary Outcomes

Assessment of local skin irritation at patch sites

Time frame: Daily for 21 days, Days 2 through 22

Secondary Outcomes

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

Time frame: Days 1 through 22, + 28 days after last product administration

Data from ClinicalTrials.gov

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