Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch

Phase 1

• Conditions: Cumulative Irritation and Sensitization
• Interventions: Drug: HP-1050 Patch

• Registration Number: NCT04624867
• Lead Sponsor: Noven Pharmaceuticals, Inc.

Brief Summary

A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.

Detailed Description

This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. 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 Timeline

• Study First Submitted: 2020-10-22
• Study Start: 2020-11-03
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;
• Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;
• Subjects who are willing to stop using any current contraceptives for the duration of the study;

Exclusion Criteria

• Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;
• Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;
• Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HP-1050 patch	HP-1050 Patch	HP-1050 and Xulane will be administered simultaneously.

Primary Outcome Measures

Name	Time	Method
Skin Irritation Evaluation	21 days	To evaluate skin irritation after exposure to HP-1050 compared to XULANE®
Sensitization Evaluation	48 hours	To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®

Trial Locations

Locations (1)

QPS Missouri; 🇺🇸 Springfield, Missouri, United States