Status:
COMPLETED
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
Lead Sponsor:
Therapeutics, Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the...
Eligibility Criteria
Inclusion
- Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent.
- Subject has provided written informed consent.
- Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA).
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
Exclusion
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation.
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04080206
Start Date
April 7 2020
End Date
January 20 2021
Last Update
May 10 2021
Active Locations (8)
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1
TI Site #13
Scottsdale, Arizona, United States, 85258
2
TI Site #12
Thousand Oaks, California, United States, 91320
3
TI Site #11
Miami, Florida, United States, 33147
4
TI Site #31
Batumi, Georgia