Phase
Condition
Rosacea
Warts
Skin Wounds
Treatment
Tapinarof
Vehicle Cream
Clinical 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 chronicplaque psoriasis 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 tothe Baseline visit
Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chickenpox) 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,or a positive anti-hepatitis B core antigen (anti-HBc) result
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificialsources of UV radiation within 4 weeks prior to the Baseline visit and/or plans tohave such exposures during the study which could potentially impact the subject'spsoriasis
Use of any prohibited medication within the indicated period before the first doseof study drug
Within a minimum of 5 half-lives for biologic agents:
Within 4 weeks for systemic immunosuppressive or immunomodulating agents,fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens,corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
2 weeks for immunizations with a live viral component; drugs known to possiblyworsen psoriasis, 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 ofdrug or 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 basalcell carcinoma, 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 CV system abnormalities or laboratory abnormality thatwill affect the health of the subject or interfere with interpretation of theresults
Study Design
Study Description
Connect with a study center
Dermavant Investigative Site
Edmonton, Alberta T5K 1X3
CanadaSite Not Available
Dermavant Investigative Site
Surrey, Bristish Columbia V3V 0C6
CanadaSite Not Available
Dermavant Investigative Site
Etobicoke, Ontario M9A 3P2
CanadaSite Not Available
Dermavant Investigative Site
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
Dermavant Investigative Site
Markham, Ontario L3P 1X2
CanadaSite Not Available
Dermavant Investigative Site
Oakville, Ontario L6J 7W5
CanadaSite Not Available
Dermavant Investigative Site
Ottawa, Ontario K2C 3N2
CanadaSite Not Available
Dermavant Investigative Site
Fort Smith, Arkansas 72916
United StatesSite Not Available
Dermavant Investigative Site
Fountain Valley, California 92708
United StatesSite Not Available
Dermavant Investigative Site
Fremont, California 94538
United StatesSite Not Available
Dermavant Investigative Site
Los Angeles, California 90045
United StatesSite Not Available
Dermavant Investigative Site
Oceanside, California 92056
United StatesSite Not Available
Dermavant Investigative Site
San Diego, California 92123
United StatesSite Not Available
Dermavant Investigative Site
Santa Monica, California 90404
United StatesSite Not Available
Dermavant Investigative Site
Denver, Colorado 80210
United StatesSite Not Available
Dermavant Investigative Site
Boynton Beach, Florida 33437
United StatesSite Not Available
Dermavant Investigative Site
Margate, Florida 33414
United StatesSite Not Available
Dermavant Investigative Site
Miami, Florida 33144
United StatesSite Not Available
Dermavant Investigative Site
Boise, Idaho 83713
United StatesSite Not Available
Dermavant Investigative Site
Rolling Meadows, Illinois 60008
United StatesSite Not Available
Dermavant Investigative Site
Plainfield, Indiana 46168
United StatesSite Not Available
Dermavant Investigative Site
Overland Park, Kansas 66215
United StatesSite Not Available
Dermavant Investigative Site
Louisville, Kentucky 40217
United StatesSite Not Available
Dermavant Investigative Site
Owensboro, Kentucky 42301
United StatesSite Not Available
Dermavant Investigative Site
Metairie, Louisiana 70006
United StatesSite Not Available
Dermavant Investigative Site
Boston, Massachusetts 02215
United StatesSite Not Available
Dermavant Investigative Site
Bay City, Michigan 48706
United StatesSite Not Available
Dermavant Investigative Site
Detroit, Michigan 48202
United StatesSite Not Available
Dermavant Investigative Site
Fort Gratiot, Michigan 48059
United StatesSite Not Available
Dermavant Investigative Site
Fridley, Minnesota 55432
United StatesSite Not Available
Dermavant Investigative Site
Omaha, Nebraska 68144
United StatesSite Not Available
Dermavant Investigative Site
Las Vegas, Nevada 89148
United StatesSite Not Available
Dermavant Investigative Site
East Windsor, New Jersey 08520
United StatesSite Not Available
Dermavant Investigative Site
Hackensack, New Jersey 07601
United StatesSite Not Available
Dermavant Investigative Site
Stony Brook, New York 11790
United StatesSite Not Available
Dermavant Investigative Site
Wilmington, North Carolina 28405
United StatesSite Not Available
Dermavant Investigative Site
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Dermavant Investigative Site
Beachwood, Ohio 44122
United StatesSite Not Available
Dermavant Investigative Site
Bexley, Ohio 43209
United StatesSite Not Available
Dermavant Investigative Site
Portland, Oregon 97223
United StatesSite Not Available
Dermavant Investigative Site
Charleston, South Carolina 29414
United StatesSite Not Available
Dermavant Investigative Site
Nashville, Tennessee 37215
United StatesSite Not Available
Dermavant Investigative Site
Houston, Texas 77056
United StatesSite Not Available
Dermavant Investigative Site
Pflugerville, Texas 78660
United StatesSite Not Available
Dermavant Investigative Site
Plano, Texas 75024
United StatesSite Not Available
Dermavant Investigative Site
San Antonio, Texas 78229
United StatesSite Not Available
Dermavant Investigative Site
Webster, Texas 77598
United StatesSite Not Available
Dermavant Investigative Site
Norfolk, Virginia 23502
United StatesSite Not Available
Dermavant Investigative Site
Spokane, Washington 99202
United StatesSite Not Available

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