Back to resultsIrritation and Sensitization Study of HP-5000 Topical System
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HP-5000 Topical Patch
HP-5000 Placebo Patch
Saline Patch
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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.
Sites / Locations
- TKL Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HP-5000 Topical Patch
Arm Description
HP-5000, placebo and saline will be administered simultaneously.
Outcomes
Primary Outcome Measures
Evaluating skin irritation with Mean Irritation Score (MIS)
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
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
Secondary Outcome Measures
Full Information
NCT ID
NCT04882319
First Posted
May 3, 2021
Last Updated
August 19, 2022
Sponsor
Noven Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04882319
Brief Title
Irritation and Sensitization Study of HP-5000 Topical System
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noven Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP-5000 Topical Patch
Arm Type
Experimental
Arm Description
HP-5000, placebo and saline will be administered simultaneously.
Intervention Type
Drug
Intervention Name(s)
HP-5000 Topical Patch
Other Intervention Name(s)
HP-5000 Patch
Intervention Description
HP-5000, placebo and saline will be administered simultaneously
Intervention Type
Drug
Intervention Name(s)
HP-5000 Placebo Patch
Other Intervention Name(s)
Placebo Control
Intervention Description
HP-5000, placebo and saline will be administered simultaneously
Intervention Type
Drug
Intervention Name(s)
Saline Patch
Other Intervention Name(s)
Saline Control
Intervention Description
HP-5000, placebo and saline will be administered simultaneously
Primary Outcome Measure Information:
Title
Evaluating skin irritation with Mean Irritation Score (MIS)
Description
To evaluate skin irritation after exposure to HP-5000, placebo and saline.
Time Frame
21 days
Title
Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics
Description
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Noven Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TKL Research
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Irritation and Sensitization Study of HP-5000 Topical System
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