NCT04624867

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

A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cumulative Irritation and Sensitization

Interventions

Type	Name	Description
DRUG	HP-1050 Patch	Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.

Timeline

• Start date: 2020-11-03
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2020-11-12
• Last updated: 2021-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study