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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Georgia, Ukraine, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions


Experimental: 188-0551 Spray

Investigational Topical Spray Product

Active Comparator: Reference Listed Drug (RLD)

FDA Approved Topical Cream


Drug: - 188-0551 Spray

Applied topically twice daily for two weeks

Drug: - RLD

Applied topically twice daily for two weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

TI Site #13, Scottsdale, Arizona




TI Site #13

Scottsdale, Arizona, 85258

TI Site #12, Thousand Oaks, California




TI Site #12

Thousand Oaks, California, 91320

TI Site #11, Miami, Florida




TI Site #11

Miami, Florida, 33147

International Sites

TI Site #31, Batumi, Georgia




TI Site #31

Batumi, ,

TI Site #32, Tbilisi, Georgia




TI Site #32

Tbilisi, ,

TI Site #23, Lviv, Ukraine




TI Site #23

Lviv, ,

TI Site #22, Rivne, Ukraine




TI Site #22

Rivne, ,

TI Site #21, Zaporizhzhya, Ukraine




TI Site #21

Zaporizhzhya, ,

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