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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 : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Noven Therapeutics ( Noven Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE May 3, 2021
First Posted Date  ICMJE May 11, 2021
Last Update Posted Date May 11, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2021)
  • Evaluating skin irritation with Mean Irritation Score (MIS) [ Time Frame: 21 days ]
    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 [ Time Frame: 21 days ]
    To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irritation and Sensitization Study of HP-5000 Topical System
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously.
Interventions:
  • Drug: HP-5000 Topical Patch
  • Drug: HP-5000 Placebo Patch
  • Drug: Saline Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Director (305) 253-5099 ClinicalTrials@noven.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04882319
Other Study ID Numbers  ICMJE HP-5000-US-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Noven Therapeutics ( Noven Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Noven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Noven Pharmaceuticals, Inc.
PRS Account Noven Therapeutics
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP