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Completed

NCT Number: NCT01787448

RIPT of Ibuprofen Topical Gel

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.

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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 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

Treatment and study plan

Topical Gel Vehicle

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%

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)

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

Primary outcomes

  1. Dermal sensitization potential

    Time frame: 24-72 hours after last patch removal

Secondary outcomes

  1. Cumulative Irritancy

    Time frame: 48-72 hours after each patch application

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

    Time frame: During study through 28 days after last product application

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 8, 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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