Irritation and Sensitization Study of HP-5000 Topical System

NCT04882319 | Completed Phase 1 FDA Drug

• 1 other identifier: HP-5000-US-06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (2)

• Evaluating skin irritation with Mean Irritation Score (MIS)

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

  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.

  21 days

Study Arms (1)

HP-5000 Topical Patch

EXPERIMENTAL

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

Drug: HP-5000 Topical Patch; Drug: HP-5000 Placebo Patch; Drug: Saline Patch

Interventions

HP-5000 Topical Patch DRUG

HP-5000, placebo and saline will be administered simultaneously

Also known as: HP-5000 Patch

HP-5000 Topical Patch

HP-5000 Placebo Patch DRUG

HP-5000, placebo and saline will be administered simultaneously

Also known as: Placebo Control

HP-5000 Topical Patch

Saline Patch DRUG

HP-5000, placebo and saline will be administered simultaneously

Also known as: Saline Control

HP-5000 Topical Patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noven Pharmaceuticals, Inc.: lead

Study Sites (1)

TKL Research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Study Director

  Noven Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: June 3, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 11, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)