NCT04882319

Irritation and Sensitization Study of HP-5000 Topical System

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	HP-5000 Topical Patch	HP-5000, placebo and saline will be administered simultaneously
DRUG	HP-5000 Placebo Patch	HP-5000, placebo and saline will be administered simultaneously
DRUG	Saline Patch	HP-5000, placebo and saline will be administered simultaneously

Timeline

• Start date: 2021-06-03
• Primary completion: 2022-03-08
• Completion: 2022-03-11
• First posted: 2021-05-11
• Last updated: 2022-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study