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Completed

NCT Number: NCT01771822

Ibuprofen 5% Topical Gel CIPT

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.

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Carlstadt, New Jersey, 07652, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen 5% topical gel

Drug

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

Topical Gel Vehicle

Drug

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

Sodium lauryl sulfate 0.2%

Drug

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

Sodium chloride solution 0.9% (saline)

Drug

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

Primary outcomes

  1. Assessment of local skin irritation at patch sites

    Time frame: Daily for 21 days, Days 2 through 22

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Days 1 through 22, + 28 days after last product administration

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 18, 2013
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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