Irritation and Sensitization Study of HP-5000 Topical System

August 19, 2022 updated by: Noven Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • TKL Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously.
Drug: HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously
Other Names:
  • HP-5000 Patch
Drug: HP-5000 Placebo Patch
HP-5000, placebo and saline will be administered simultaneously
Other Names:
  • Placebo Control
Drug: Saline Patch
HP-5000, placebo and saline will be administered simultaneously
Other Names:
  • Saline Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating skin irritation with Mean Irritation Score (MIS)
Time Frame: 21 days
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
Time Frame: 21 days
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noven Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2021

Primary Completion (ACTUAL)

March 8, 2022

Study Completion (ACTUAL)

March 11, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (ACTUAL)

May 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-5000-US-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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