Trial | NCT03630939  Report issue

Title

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis
A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ESR-114 ...

  • Study Participants

    104
This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).
Study Started
Aug 09
2018
Primary Completion
Jun 05
2019
Study Completion
Jun 12
2019
Last Update
Jul 29
2020

Drug ESR-114

ESR-114 Topical Gel

Other Placebo

Placebo Topical Gel

ESR-114 1.5% Experimental

ESR-114 1.5% Topical Gel BID for 6 weeks

ESR-114 5.0% Experimental

ESR-114 5.0% Topical Gel BID for 6 weeks

Vehicle Gel Placebo Comparator

Placebo Topical Gel BID for 6 weeks

Criteria 

Inclusion Criteria:

Subject has a history of plaque psoriasis for at least 6 months.
Subject has PGA of mild (2) or moderate (3) at Day 1.
Subject has total LSS of ≥6 at Day 1.
Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.

Exclusion Criteria:

Subject has non-plaque psoriasis at Screening and Day 1.
Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.
No Results Posted