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



Status:Recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:12/29/2018
Start Date:August 9, 2018
End Date:June 11, 2019
Contact:MiRa Huyghe
Email:mhuyghe@escalierbio.com
Phone:1 760 456 2012

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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

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).


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.
We found this trial at
9
sites
Fridley, Minnesota 55432
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Fridley, MN
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Austin, Texas
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Austin, TX
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1710 Crescent Pointe Parkway
College Station, Texas 77845
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College Station, TX
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Houston, Texas 77004
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Houston, TX
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Peterborough, Ontario
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Peterborough,
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Raleigh, North Carolina 27612
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Raleigh, NC
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San Antonio, Texas
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San Antonio, TX
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Santa Monica, California
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Santa Monica, CA
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Tampa, Florida
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Tampa, FL
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