Irritation and Sensitization Study of HP-5000 Topical System

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882319
• Other study ID #: HP-5000-US-06
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2021
• Est. completion date: March 11, 2022

Study information

• Verified date: August 2022
• Source: Noven Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 11, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• HP-5000 Topical Patch
HP-5000, placebo and saline will be administered simultaneously
• HP-5000 Placebo Patch
HP-5000, placebo and saline will be administered simultaneously
• Saline Patch
HP-5000, placebo and saline will be administered simultaneously

Locations

Country	Name	City	State
United States	TKL Research	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Noven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating skin irritation with Mean Irritation Score (MIS)	To evaluate skin irritation after exposure to HP-5000, placebo and saline.	21 days
Primary	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.	21 days