Ibuprofen 5% Topical Gel CIPT

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Sodium lauryl sulfate 0.2%; Drug: Topical gel vehicle; Drug: Ibuprofen 5% topical gel; Drug: Sodium chloride solution 0.9% (saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01771822

B3491004

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Ibuprofen 5% topical gel

Experimental group

Treatment:

Drug: Ibuprofen 5% topical gel

Topical gel vehicle

Experimental group

Treatment:

Drug: Topical gel vehicle

Sodium lauryl sulfate 0.2%

Active Comparator group

Treatment:

Drug: Sodium lauryl sulfate 0.2%

Sodium chloride solution 0.9% (saline)

Sham Comparator group

Treatment:

Drug: Sodium chloride solution 0.9% (saline)