Irritation and Sensitization Study of HP-5000 Topical System

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

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

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.

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.