Irritation and Sensitization Study of HP-5000 Topical System

NCT ID: NCT04882319

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2022-03-11

Brief Summary

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

Detailed 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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HP-5000 Topical Patch

HP-5000, placebo and saline will be administered simultaneously.

Group Type: EXPERIMENTAL

HP-5000 Topical Patch

Intervention Type: DRUG

HP-5000, placebo and saline will be administered simultaneously

HP-5000 Placebo Patch

Intervention Type: DRUG

HP-5000, placebo and saline will be administered simultaneously

Saline Patch

Intervention Type: DRUG

HP-5000, placebo and saline will be administered simultaneously

Interventions

HP-5000 Topical Patch

HP-5000, placebo and saline will be administered simultaneously

Intervention Type: DRUG

HP-5000 Placebo Patch

HP-5000, placebo and saline will be administered simultaneously

Intervention Type: DRUG

Saline Patch

HP-5000, placebo and saline will be administered simultaneously

Intervention Type: DRUG

Other Intervention Names

HP-5000 Patch; Placebo Control; Saline Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Noven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Noven Pharmaceuticals, Inc.

Locations

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

HP-5000-US-06

Identifier Type: -

Identifier Source: org_study_id