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Irritation and Sensitization Study of HP-5000 Topical System

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ClinicalTrials.gov Identifier: NCT04882319
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics ( Noven Pharmaceuticals, Inc. )

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 3, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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 Name: HP-5000 Patch

Drug: HP-5000 Placebo Patch
HP-5000, placebo and saline will be administered simultaneously
Other Name: Placebo Control

Drug: Saline Patch
HP-5000, placebo and saline will be administered simultaneously
Other Name: Saline Control




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882319


Contacts
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Contact: Study Director (305) 253-5099 ClinicalTrials@noven.com

Locations
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United States, New Jersey
TKL Research Recruiting
Fair Lawn, New Jersey, United States, 07410
Contact: Study Director         
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Study Director: Study Director Noven Pharmaceuticals, Inc.
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Responsible Party: Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04882319    
Other Study ID Numbers: HP-5000-US-06
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases