NCT01787448
Completed
Phase 1
Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
ConditionsPain
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Dermal sensitization potential
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ibuprofen 5% topical gel
Experimental
Intervention: Topical gel vehicle (Drug)
Topical gel vehicle
Experimental
Intervention: Topical gel vehicle (Drug)
Sodium lauryl sulfate 0.1%
Active Comparator
Intervention: Sodium lauryl sulfate 0.1% (Drug)
Sodium chloride solution 0.9% (saline)
Sham Comparator
Intervention: Sodium chloride solution 0.9% (saline) (Drug)
Outcomes
Primary Outcomes
Dermal sensitization potential
Time Frame: 24-72 hours after last patch removal
Secondary Outcomes
- Cumulative Irritancy(48-72 hours after each patch application)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(During study through 28 days after last product application)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Ibuprofen 5% Topical Gel CIPTPainNCT01771822Pfizer50
Completed
Phase 3
Topical Ibuprofen for Delayed Onset Mulscle SorenessPainNCT01794923Pfizer205
Completed
Phase 2
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMSPain, AcuteNCT03852459Aponia Laboratories, Inc.251
Unknown
Phase 3
Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g GelMuscular AtrophySprainsTendonitisNCT01373697Laboratório Teuto Brasileiro S/A144
Completed
Phase 3
5% Topical Ibuprofen (IBU) for Ankle SprainAnkle InjuriesNCT01945034Pfizer304