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Ibuprofen 5% Topical Gel CIPT

NCT ID: NCT01771822

Last Updated: 2013-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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cumulative irritancy patch test (CIPT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ibuprofen 5% topical gel

Group Type EXPERIMENTAL

Ibuprofen 5% topical gel

Intervention Type DRUG

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

Topical gel vehicle

Group Type EXPERIMENTAL

Topical gel vehicle

Intervention Type DRUG

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

Sodium lauryl sulfate 0.2%

Group Type ACTIVE_COMPARATOR

Sodium lauryl sulfate 0.2%

Intervention Type DRUG

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

Sodium chloride solution 0.9% (saline)

Group Type SHAM_COMPARATOR

Sodium chloride solution 0.9% (saline)

Intervention Type DRUG

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

Interventions

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Ibuprofen 5% topical gel

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

Intervention Type DRUG

Topical gel vehicle

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

Intervention Type DRUG

Sodium lauryl sulfate 0.2%

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

Intervention Type DRUG

Sodium chloride solution 0.9% (saline)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Carlstadt, New Jersey, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3491004&StudyName=Ibuprofen%205%25%20Topical%20Gel%20CIPT

To obtain contact information for a study center near you, click here.

Other Identifiers

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B3491004

Identifier Type: -

Identifier Source: org_study_id