NCT03004339

Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test

A Phase 1 Randomized, Placebo and Active Comparator-controlled Trial, Double-blind for the IPs, Observer-blind for the Active Comparator, to Assess the Potency of SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment in a Psoriasis Plaque Test

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: DFB Soria, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of safety, pharmacokinetics, and anti-psoriatic efficacy to assess SOR007 Ointment in topical formulations

Detailed description

This is a two-center, randomized, placebo- and active comparator-controlled trial that will be double-blind for the investigational products (IPs) and observer-blind for the active comparator with intra-individual comparison of treatments. Twelve male and post-menopausal female volunteer subjects, aged 18 years or older, with psoriasis vulgaris and mild or moderate chronic plaque(s) in a stable phase and an area sufficient for six treatment fields, will be enrolled. SOR007 Ointment will be administered topically at four concentrations (0.15%, 0.3%, 1%, and 2%), in addition to a placebo ointment (SOR007 without the active pharmaceutical ingredient) and an active comparator, Taclonex® Ointment (calcipotriene 0.005 % and betamethasone dipropionate 0.064 %). Treatments will be administered once daily, 10 times over a 12-day trial period. Assessments will include safety, pharmacokinetics (PK), and preliminary efficacy as determined by measurement of psoriatic infiltrate using 22-megahertz (MHz) sonography as well as clinical scoring on a 5-point scale. Subjects who withdraw early for reasons unrelated to investigational product adverse events (AEs) will be replaced.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	SOR007 Ointment 2.0%
DRUG	SOR007 Ointment 1.0%
DRUG	SOR007 Ointment 0.3%
DRUG	SOR007 Ointment 0.15%
DRUG	SOR007 Ointment Placebo
DRUG	Taclonex® Ointment

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-02-13
• Completion: 2017-02-13
• First posted: 2016-12-28
• Last updated: 2019-02-15

Locations

2 sites across 1 country: United States