RIPT of Ibuprofen Topical Gel

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Topical gel vehicle
* Drug: Topical gel vehicle
* Drug: Sodium lauryl sulfate 0.1%
* Drug: Sodium chloride solution 0.9% (saline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen 5% topical gel<br> | Drug: Topical gel vehicle<br>* 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<br>|
| Experimental: Topical gel vehicle<br> | Drug: Topical gel vehicle<br>* 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<br>|
| Active Comparator: Sodium lauryl sulfate 0.1%<br> | Drug: Sodium lauryl sulfate 0.1%<br>* 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<br>|
| Sham Comparator: Sodium chloride solution 0.9% (saline)<br> | Drug: Sodium chloride solution 0.9% (saline)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal sensitization potential |  | 24-72 hours after last patch removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repeat insult patch test