Ibuprofen 5% Topical Gel CIPT

Pfizer logo

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems