Pharmaceutical company assesses skin irritation and sensitization for HP-1050 patch
Photo by Marius Spita
The specialty pharmaceutical company Noven Pharmaceuticals, Inc is conducting the study that will assess skin irritation and sensitization for HP-1050 patch.
This is a 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.
Actual study start date is November 3, 2020. The researchers expect to complete the study by September 2021.
Skin Irritation Evaluation and Sensitization Evaluation are the primary outcome measures.
The study population that can be enrolled into this study includes
- Healthy non-pregnant, non-lactating females 18-35 years of age.
- Participants who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated.
- Participants who are willing to stop using any current contraceptives for the duration of the study.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04624867) Springfield, United States.
