Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title: (V01-118A-03) A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

Status Recruiting

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety of topical IDP-118 lotion following once daily, 8-week treatment courses in subjects with plaque psoriasis followed by intermittent as needed treatment for up to 1-year. Subjects will receive treatment courses as needed during the year to manage their plaques psoriasis with following safety endpoint evaluations being conducted.

Clinical Trial Description

Eligible male and female participants must be greater than or equal to 18 years old, have an area of plaque Psoriasis, and not be, or plan to be, pregnant or breast feeding during the study. Subjects must be available for at least 7 office visits during the 17 week period and be willing to comply with all study instructions. Several other restrictions and criteria may apply that the study doctor will review with you to determine if you qualify to enter the study.

The subject will be instructed on how to treat the affected areas. Subjects will be instructed to squeeze a small amount of study drug (pea-sized) onto a fingertip and then spread a thin layer of the study drug over the affected area once daily up to week 8. The in-office study visits will be approximately 2 weeks apart and include assessment of the psoriasis-affected body surface area, as well as periodic small blood draws.

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in subjects with plaque psoriasis. This means it is not approved by the FDA, but that it can be tested in research studies like this one. IDP-118 lotion is a combination product, containing halobetasol propionate 0.01% and tazarotene 0.045%, both separately FDA approved and available for the treatment of plaque psoriasis. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

• NCT number: NCT02611349
• Study type: Interventional
• Source: Sadick Research Group
• Contact: Laura Donohue
• Phone: 2127727242
• Email: ldonohue@sadickdermatology.com
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2015
• Completion date: September 2016