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RIPT of Ibuprofen Topical Gel

NCT ID: NCT01787448

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

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Keywords

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repeat insult patch test

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

Topical gel vehicle

Intervention Type DRUG

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Topical gel vehicle

Group Type EXPERIMENTAL

Topical gel vehicle

Intervention Type DRUG

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Sodium lauryl sulfate 0.1%

Group Type ACTIVE_COMPARATOR

Sodium lauryl sulfate 0.1%

Intervention Type DRUG

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Sodium chloride solution 0.9% (saline)

Group Type SHAM_COMPARATOR

Sodium chloride solution 0.9% (saline)

Intervention Type DRUG

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Interventions

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Topical gel vehicle

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Intervention Type DRUG

Topical gel vehicle

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Intervention Type DRUG

Sodium lauryl sulfate 0.1%

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Intervention Type DRUG

Sodium chloride solution 0.9% (saline)

0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application

Intervention Type DRUG

Eligibility Criteria

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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
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=B3491007&StudyName=RIPT%20of%20ibuprofen%20topical%20gel

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

Other Identifiers

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B3491007

Identifier Type: -

Identifier Source: org_study_id