RIPT of Ibuprofen Topical Gel

Overview

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.

Full Title of Study: “Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

Interventions

  • 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
  • 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
  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: Ibuprofen 5% topical gel
  • Experimental: Topical gel vehicle
  • Active Comparator: Sodium lauryl sulfate 0.1%
  • Sham Comparator: Sodium chloride solution 0.9% (saline)

Clinical Trial Outcome Measures

Primary Measures

  • Dermal sensitization potential
    • Time Frame: 24-72 hours after last patch removal

Secondary Measures

  • Cumulative Irritancy
    • Time Frame: 48-72 hours after each patch application
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    • Time Frame: During study through 28 days after last product application

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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