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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03630939

Enrollment

104

Registered

2018-08-15

Start date

2018-08-09

Completion date

2019-06-12

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Plaque

Brief summary

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).

Interventions

DRUGESR-114

ESR-114 Topical Gel

OTHERPlacebo

Placebo Topical Gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Total Lesion Severity Score	6 weeks	Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, & Desquamation; score range: 0-12; lower score is better outcome) at Week 6

Secondary

Measure	Time frame	Description
Proportion of subjects with clear or almost clear on the Physician Global Assessment	6 weeks	Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6
Proportion of subjects with PASI75	6 weeks	Proportion of subjects with PASI75 at Week 6
Change from Baseline in erythema score over time	6 weeks	Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Change from Baseline in induration score over time	6 weeks	Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Change from Baseline in desquamation score over time	6 weeks	Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026