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Completed

NCT Number: NCT04882319

Irritation and Sensitization Study of HP-5000 Topical System

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL Research

Fair Lawn, New Jersey, 07410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HP-5000 Topical Patch

Drug

HP-5000, placebo and saline will be administered simultaneously

Other names: HP-5000 Patch

HP-5000 Placebo Patch

Drug

HP-5000, placebo and saline will be administered simultaneously

Other names: Placebo Control

Saline Patch

Drug

HP-5000, placebo and saline will be administered simultaneously

Other names: Saline Control

Primary outcomes

  1. Evaluating skin irritation with Mean Irritation Score (MIS)

    Time frame: 21 days

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

  2. Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics

    Time frame: 21 days

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

Sponsors and collaborators

Lead sponsor

Noven Pharmaceuticals, Inc.

Industry

Registry information

Official study title

An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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