Irritation and Sensitization Study of HP-5000 Topical System

Phase 1

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: HP-5000 Topical Patch; Drug: HP-5000 Placebo Patch; Drug: Saline Patch

• Registration Number: NCT04882319
• Lead Sponsor: Noven Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-11
• Study Start: 2021-06-03
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HP-5000 Topical Patch	HP-5000 Topical Patch	HP-5000, placebo and saline will be administered simultaneously.
HP-5000 Topical Patch	HP-5000 Placebo Patch	HP-5000, placebo and saline will be administered simultaneously.
HP-5000 Topical Patch	Saline Patch	HP-5000, placebo and saline will be administered simultaneously.

Primary Outcome Measures

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

Trial Locations

Locations (1)

TKL Research; 🇺🇸 Fair Lawn, New Jersey, United States