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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882319
Enrollment
200
Registered
2021-05-11
Start date
2021-06-03
Completion date
2022-03-11
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

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.

Interventions

DRUGHP-5000 Topical Patch

HP-5000, placebo and saline will be administered simultaneously

DRUGHP-5000 Placebo Patch

HP-5000, placebo and saline will be administered simultaneously

DRUGSaline Patch

HP-5000, placebo and saline will be administered simultaneously

Sponsors

Noven Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluating skin irritation with Mean Irritation Score (MIS)21 daysTo evaluate skin irritation after exposure to HP-5000, placebo and saline.
Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics21 daysTo evaluate skin sensitization after exposure to HP-5000, placebo and saline.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026