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Irritation and Sensitization Study of HP-5000 Topical System

Sponsor
Noven Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04882319
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
9.2
Actual Duration (Months)
21.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: HP-5000 Topical Patch
  • Drug: HP-5000 Placebo Patch
  • Drug: Saline Patch
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jun 3, 2021
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Mar 11, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluating skin irritation with Mean Irritation Score (MIS) [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 [21 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TKL Research Fair Lawn New Jersey United States 07410

    Sponsors and Collaborators

    • Noven Pharmaceuticals, Inc.

    Investigators

    • Study Director: Study Director, Noven Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noven Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04882319
    Other Study ID Numbers:
    • HP-5000-US-06
    First Posted:
    May 11, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Aug 23, 2022