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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT03630939•Escalier Biosciences B.V.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (10)

Study Site 19

Santa Monica, California, United States

Study Site 16

Tampa, Florida, United States

Study Site 17

Fridley, Minnesota, United States

Study Site 14

Raleigh, North Carolina, United States

Study Site 12

Austin, Texas, United States

Study Site 11

College Station, Texas, United States

Study Site 15

Houston, Texas, United States

Study Site 18

San Antonio, Texas, United States

Study Site 13

Peterborough, Ontario, Canada

Study Site 10

Montreal, Quebec, Canada

Key Dates

Start Date

August 9, 2018

Primary Completion Date

June 5, 2019

Completion Date

June 12, 2019

Last Updated

July 29, 2020

Enrollment

104

ACTUAL participants

Conditions

Psoriatic Plaque

Interventions

ESR-114

DRUG

Placebo

OTHER

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

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PsoriasisPsoriasis Vulgaris+12 more

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COMPLETEDPHASE2

A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis

NCT04911751

Psoriatic Plaque

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis

Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines