Phase
Condition
Warts
Rosacea
Scalp Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaquepsoriasis and stable disease for at least 6 months prior to the study.
- BSA involvement ≥ 3% and ≤ 20%
- A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
- Females of child bearing potential and male subjects who are engaging in sexualactivity that could lead to pregnancy agree to follow the specified contraceptiveguidance throughout the study, including screening, during the treatment period, andfor at least 4 weeks after the last exposure to study treatment
- Capable of giving written informed consent
Exclusion
Exclusion Criteria:
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Concurrent conditions or history of other diseases:
- Immunocompromised at Screening
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals,antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baselinevisit
- Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox)skin infection within 1 week prior to the Baseline visit
- Significant dermatologic or inflammatory condition other than plaque psoriasis that,in the Investigator's opinion, would make it difficult to interpret data orassessments during the study
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upperlimit of normal (ULN)
- Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable ifbilirubin is fractionated and direct bilirubin < 35%
- Corrected QT interval > 475
- Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence ofhepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, ora positive anti-hepatitis B core antigen (anti-HBc) result
- Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sourcesof UV radiation within 4 weeks prior to the Baseline visit and/or plans to have suchexposures during the study which could potentially impact the subject's psoriasis
- Use of any prohibited medication within the indicated period before the first dose ofstudy drug
- Within a minimum of 5 half-lives for biologic agents:
- Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acidderivatives, vitamin D3 and analogs, retinoids, psoralens, corticosteroids,adrenocorticotropic hormone analogs, and tazarotene
- 2 weeks for immunizations with a live viral component; drugs known to possibly worsenpsoriasis, unless on a stable dose for > 12 weeks
- With the exception of non-medicated emollients, 2 weeks for topical treatmentsincluding corticosteroids, immunomodulators, anthralin (dithranol), vitamin Dderivatives or coal tar.
- Pregnant females or lactating females
- History of sensitivity to the study drugs, or components thereof or a history of drugor other allergy that, in the opinion of the Investigator or Medical Monitor,contraindicates the subject's participation in the study
- The subject has received an investigational product within 30 days, 5 half-lives, ortwice the duration of the biological effect of the study drug (whichever is longer)prior to first dose of study drug
- Current or a history of cancer within 5 years except for fully excised skin basal cellcarcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Subjects with active infection that required oral, intramuscular, or intravenousadministration of antibiotics, antifungal or antiviral agents within 7 days ofBaseline/Day 1
- Previous known participation in a clinical study with tapinarof
- Evidence of significant hepatic, renal, respiratory, endocrine, hematologic,neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratoryabnormality that will affect the health of the subject or interfere withinterpretation of the results
Study Design
Study Description
Connect with a study center
Dermavant Investigative Site
Saint Johns, Newfoundland and Labrador A1C 2H5
CanadaSite Not Available
Dermavant Investigative Site
Ajax, Ontario L1S 7K8
CanadaSite Not Available
Dermavant Investigative Site
Coburg, Ontario K9A 0Z4
CanadaSite Not Available
Dermavant Investigative Site
North Bay, Ontario P1B 3Z7
CanadaSite Not Available
Dermavant Investigative Site
Richmond Hill, Ontario L4C 9M7
CanadaSite Not Available
Dermavant Investigative Site
Toronto, Ontario M3H 5Y8
CanadaSite Not Available
Dermavant Investigative Site
Waterloo, Ontario N2J 1C4
CanadaSite Not Available
Dermavant Investigative Site
Windsor, Ontario N8W 5L7
CanadaSite Not Available
Dermavant Investigative Site
Montréal, Quebec H2X 2V1
CanadaSite Not Available
Dermavant Investigative Site
Birmingham, Alabama 35205
United StatesSite Not Available
Dermavant Investigative Site
Phoenix, Arizona 85032
United StatesSite Not Available
Dermavant Investigative Site
Hot Springs, Arkansas 71913
United StatesSite Not Available
Dermavant Investigative Site
Rogers, Arkansas 72758
United StatesSite Not Available
Dermavant Investigative Site
Anaheim Hills, California 92807
United StatesSite Not Available
Dermavant Investigative Site
Fresno, California 93720
United StatesSite Not Available
Dermavant Investigative Site
Los Angeles, California 90033
United StatesSite Not Available
Dermavant Investigative Site
Northridge, California 91324
United StatesSite Not Available
Dermavant Investigative Site
San Diego, California 92123
United StatesSite Not Available
Dermavant Investigative Site
Santa Ana, California 92701
United StatesSite Not Available
Dermavant Investigative Site
Cromwell, Connecticut 06416
United StatesSite Not Available
Dermavant Investigative Site
Boca Raton, Florida 33431
United StatesSite Not Available
Dermavant Investigative Site
Brandon, Florida 33511
United StatesSite Not Available
Dermavant Investigative Site
Hialeah, Florida 33016
United StatesSite Not Available
Dermavant Investigative Site
Miramar, Florida 33027
United StatesSite Not Available
Dermavant Investigative Site
Marietta, Georgia 30060
United StatesSite Not Available
Dermavant Investigative Site
Evansville, Indiana 47714
United StatesSite Not Available
Dermavant Investigative Site
Indianapolis, Indiana 46250
United StatesSite Not Available
Dermavant Investigative Site
New Albany, Indiana 47150
United StatesSite Not Available
Dermavant Investigative Site
Louisville, Kentucky 40202
United StatesSite Not Available
Dermavant Investigative Site
Owensboro, Kentucky 42301
United StatesSite Not Available
Dermavant Investigative Site
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Dermavant Investigative Site
New Orleans, Louisiana 70112
United StatesSite Not Available
Dermavant Investigative Site
Boston, Massachusetts 02115
United StatesSite Not Available
Dermavant Investigative Site
Clarkston, Michigan 48346
United StatesSite Not Available
Dermavant Investigative Site
Warren, Michigan 48088
United StatesSite Not Available
Dermavant Investigative Site
Saint Joseph, Missouri 64506
United StatesSite Not Available
Dermavant Investigative Site
Verona, New Jersey 07044
United StatesSite Not Available
Dermavant Investigative Site
Forest Hills, New York 11375
United StatesSite Not Available
Dermavant Investigative Site
Kew Gardens, New York 11374
United StatesSite Not Available
Dermavant Investigative Site
New York, New York 10029
United StatesSite Not Available
Dermavant Investigative Site
Rochester, New York 14623
United StatesSite Not Available
Dermavant Investigative Site
Cary, North Carolina 27518
United StatesSite Not Available
Dermavant Investigative Site
High Point, North Carolina 27262
United StatesSite Not Available
Dermavant Investigative Site
Norman, Oklahoma 73071
United StatesSite Not Available
Dermavant Investigative Site
Portland, Oregon 97210
United StatesSite Not Available
Dermavant Investigative Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Dermavant Investigative Site
Johnston, Rhode Island 02919
United StatesSite Not Available
Dermavant Investigative Site
Arlington, Texas 76011
United StatesSite Not Available
Dermavant Investigative Site
College Station, Texas 77802
United StatesSite Not Available
Dermavant Investigative Site
Dripping Springs, Texas 78620
United StatesSite Not Available
Dermavant Investigative Site
Houston, Texas 77004
United StatesSite Not Available
Dermavant Investigative Site
San Antonio, Texas 78213
United StatesSite Not Available
Dermavant Investigative Site
West Jordan, Utah 84088
United StatesSite Not Available
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