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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
240
Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.
QPS Missouri
Springfield, Missouri, United States
RECRUITINGSkin Irritation Evaluation
To evaluate skin irritation after exposure to HP-1050 compared to XULANE®
Time frame: 21 days
Sensitization Evaluation
To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®
Time frame: 48 hours
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