Irritation and Sensitization Study of HP-5000 Topical System

Study Overview
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Brief Summary
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This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.

Detailed Description
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This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.

Official Title
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An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: HP-5000 Topical Patch
* Drug: HP-5000 Placebo Patch
* Drug: Saline Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides written informed consent prior to entering the study or undergoing any study procedures; Subject is a generally healthy male or female 18 to 65 years of age; Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results. Exclusion Criteria: Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial; Subject has severe cardiac, renal or hepatic impairment; Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP-5000 Topical Patch<br>HP-5000, placebo and saline will be administered simultaneously. | Drug: HP-5000 Topical Patch<br>* HP-5000, placebo and saline will be administered simultaneously<br>* Other names: HP-5000 Patch;Drug: HP-5000 Placebo Patch<br>* HP-5000, placebo and saline will be administered simultaneously<br>* Other names: Placebo Control;Drug: Saline Patch<br>* HP-5000, placebo and saline will be administered simultaneously<br>* Other names: Saline Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating skin irritation with Mean Irritation Score (MIS) | To evaluate skin irritation after exposure to HP-5000, placebo and saline. | 21 days | 
| Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics | To evaluate skin sensitization after exposure to HP-5000, placebo and saline. | 21 days |