Irritation and Sensitization Study of HP-5000 Topical System

Noven Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis of the Knee

Treatments

Drug: HP-5000 Placebo Patch

Drug: HP-5000 Topical Patch

Drug: Saline Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT04882319

HP-5000-US-06

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.