Irritation and Sensitization Study of HP-5000 Topical System

Noven Pharmaceuticals, Inc.200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Osteoarthritis of the Knee

Interventions

HP-5000 Topical PatchDRUG

HP-5000, placebo and saline will be administered simultaneously

HP-5000 Placebo PatchDRUG

HP-5000, placebo and saline will be administered simultaneously

Saline PatchDRUG

HP-5000, placebo and saline will be administered simultaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

TKL Research

Fair Lawn, New Jersey, United States

Outcomes

Primary Outcomes

Evaluating skin irritation with Mean Irritation Score (MIS)

To evaluate skin irritation after exposure to HP-5000, placebo and saline.

Time frame: 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.

Time frame: 21 days

Data from ClinicalTrials.gov

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