A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-07

Study Completion Date

2021-01-20

Brief Summary

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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 pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.

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Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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188-0551 Spray

Investigational Topical Spray Product

Group Type EXPERIMENTAL

188-0551 Spray

Intervention Type DRUG

Applied topically twice daily for two weeks

Reference Listed Drug (RLD)

FDA Approved Topical Cream

Group Type ACTIVE_COMPARATOR

RLD

Intervention Type DRUG

Applied topically twice daily for two weeks

Interventions

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188-0551 Spray

Applied topically twice daily for two weeks

Intervention Type DRUG

RLD

Applied topically twice daily for two weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No