RIPT of Ibuprofen Topical Gel

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Sodium chloride solution 0.9% (saline); Drug: Topical gel vehicle; Drug: Sodium lauryl sulfate 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01787448

B3491007

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

234 participants in 4 patient groups

Ibuprofen 5% topical gel

Experimental group

Treatment:

Drug: Topical gel vehicle

Drug: Topical gel vehicle

Topical gel vehicle

Experimental group

Treatment:

Drug: Topical gel vehicle

Drug: Topical gel vehicle

Sodium lauryl sulfate 0.1%

Active Comparator group

Treatment:

Drug: Sodium lauryl sulfate 0.1%

Sodium chloride solution 0.9% (saline)

Sham Comparator group

Treatment:

Drug: Sodium chloride solution 0.9% (saline)