Status:
COMPLETED
Irritation and Sensitization Study of HP-5000 Topical System
Lead Sponsor:
Noven Pharmaceuticals, Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 Scree...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04882319
Start Date
June 3 2021
End Date
March 11 2022
Last Update
August 23 2022
Active Locations (1)
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1
TKL Research
Fair Lawn, New Jersey, United States, 07410