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RIPT of Ibuprofen Topical Gel

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Carlstadt, New Jersey, 07652 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01787448
Pfizer
Completed
RIPT of Ibuprofen Topical Gel

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RIPT of Ibuprofen Topical Gel
Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pain
  • 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
  • Experimental: Ibuprofen 5% topical gel
    Intervention: Drug: Topical gel vehicle
  • Experimental: Topical gel vehicle
    Intervention: Drug: Topical gel vehicle
  • Active Comparator: Sodium lauryl sulfate 0.1%
    Intervention: Drug: Sodium lauryl sulfate 0.1%
  • Sham Comparator: Sodium chloride solution 0.9% (saline)
    Intervention: Drug: Sodium chloride solution 0.9% (saline)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
February 2013
February 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01787448
B3491007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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