Phase
Condition
Warts
Rash
Scalp Disorders
Treatment
Tapinarof Cream 1%
VTAMA®
Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed ICF indicating that the patient understands the purpose of, and proceduresrequired for the study and is willing to participate in the study.
Males and non-pregnant, non-lactating females aged ≥18 at the time of signing theinformed consent.
Patients with clinical diagnosis of chronic plaque psoriasis and stable disease forat least 6 months prior to the study.
Body surface area (BSA) involvement ≥ 3% and ≤ 20% (the patient's face, scalp,groins, palms and soles should be excluded from the percent of total BSA (%BSA)calculations).
A Physician's Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe)at screening and baseline.
Female patients of childbearing potential (*WOCBP) must not be pregnant or lactatingat the time of screening/baseline visit as documented by a negative urine pregnancytest with a sensitivity to at least 25 mIU/ml hCG:
*Female patients of childbearing potential (WOCBP) are defined as sexually maturewomen without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more monthsare still considered to be of childbearing potential, if the amenorrhea is possiblydue to other causes, including prior chemotherapy, anti- estrogens, or ovariansuppression. Postmenopausal women (defined as women who have been amenorrheic for atleast 12 consecutive months, in the appropriate age group, without other known orsuspected primary cause) or women who have been sterilized surgically or who areotherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy withsurgery at least 4 weeks prior to randomization) are not considered WOCBP. Patientswho have undergone tubal ligation are NOT considered as surgically sterile.
Female patients of childbearing potential must be willing to use an acceptable formof birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
For the purposes of this study the following are considered acceptable methodsof birth control: oral or injectable contraceptives, contraceptive patches,medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for atleast 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiolvaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel orequivalent, double barrier methods, (e.g. condom and spermicide), intrauterinedevice (IUD), true abstinence (if in line with patient's lifestyle).
Patients on hormonal contraception must be stabilized on the same type for atleast three months prior to enrollment in the study and must not change themethod during the study. A sterile sexual partner is not considered an adequateform of birth control.
If a patient who was abstinent becomes sexually active during the study, asecond acceptable method of birth control should be used and documented.
Willing and able to adhere to the lifestyle restrictions specified in this protocol.
Patients must be in good health and free from any clinically significant disease,which may interfere with the evaluation of plaque psoriasis or the administration ofthe investigative product.
Patients must be willing to refrain from using all other topical plaque psoriasisproducts during the 12-week treatment period, other than the investigationalproduct.
Exclusion
Exclusion Criteria:
Known allergies, hypersensitivity, or intolerance to any of the ingredients of studytreatment interventions, or components/ excipients thereof (refer to the prescribinginformation of VTAMA®), or drug or other allergy that, in the opinion of theinvestigator, contraindicates participation in the study.
Current diagnosis of unstable forms of psoriasis (other than plaque variant) in thetreatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
Patients with other inflammatory skin disease in the treatment area that mayconfound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contactdermatitis, tinea corporis, and or any others in the opinion of the Investigator).
Presence of pigmentation, extensive scarring, or pigmented lesions in the treatmentareas, which could interfere with the rating of efficacy parameters.
Patients with current immunosuppression.
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificialsources of UV radiation (eg, phototherapy, tanning booths, or therapeuticsunbathing), laser therapy, tattoos removal, skin wraps or exfoliant techniques orFraxel within 4 weeks prior to the baseline visit and/or plans to have suchexposures during the study which could potentially impact the patient's psoriasis (as determined by the Investigator).
Use of biological treatments for psoriasis within the last 6 months of the baselineevaluation.
Patients that have been treated with systemic steroids, systemic antibiotics,systemic anti-psoriatic treatment (i.e., methotrexate, cyclosporine, hydroxyurea),PUVA therapy, ultraviolet- B Therapy or systemic anti-inflammatory agents within 1month or within 5 half-lives (whichever is longer) before Baseline.
Use of any of the following therapies within two weeks prior to baseline:
topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar,calcipotriene, tazarotene)
topical corticosteroids
immunosuppressive drugs (e.g., tacrolimus, pimecrolimus)
topical retinoids
Received an investigational intervention within 30 days or 5 half-lives prior to thefirst dose of study intervention, whichever is longer.
Documented medical history of uncontrolled, clinically significant intercurrentmedical condition(s) (i.e., chronic infectious disease, system disorder, organdisorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological,pancreatic, renal disease, severe psychiatric condition, etc.) for which, in theopinion of the investigator, participation would not be in the best interest of thepatient (e.g., compromise the well-being) or that could prevent, limit, or confoundthe protocol-specified assessments.
Employees of the Investigator or research center or their immediate family members.
Females who are pregnant, breast feeding, or who wish to become pregnant during thestudy period.
Patients who have received chemotherapy or radiation therapy and/or anti-neoplasticagents within 3 months prior to screening/baseline.
Patients who are unable or unwilling to give informed consent.
Patients, who in the opinion of the Investigator, would be non-compliant with therequirements of the study protocol.
Patients who consume excessive amounts of alcohol (greater than two drinks per day)or use drugs of abuse (including, but not limited to, cannabinoids, cocaine andbarbiturates) within one year prior to screening.
Patients who have been previously enrolled in this study.
Study Design
Study Description
Connect with a study center
Site 12107
Scottsdale, Arizona 85260
United StatesSite Not Available
Site 12101
Bryant, Arkansas 72022
United StatesSite Not Available
Site 12110
Dublin, California 94568
United StatesActive - Recruiting
Site 12112
Dublin, California 94568
United StatesSite Not Available
Site 12102
Fremont, California 94538
United StatesSite Not Available
Site 12111
Pomona, California 91767
United StatesSite Not Available
Site 12115
Ft. Lauderdale, Florida 33308
United StatesActive - Recruiting
Site 12104
Miami, Florida 33144
United StatesActive - Recruiting
Site 12113
Miami, Florida 33175
United StatesActive - Recruiting
Site 12116
Miami, Florida 33146
United StatesActive - Recruiting
Site 12114
Miramar, Florida 33027
United StatesActive - Recruiting
Site 12108
Chicago, Illinois 60614
United StatesActive - Recruiting
Site 12106
Clarksville, Indiana 47129
United StatesSite Not Available
Site 12105
Louisville, Kentucky 40241
United StatesSite Not Available
Site 12109
Las Vegas, Nevada 89121
United StatesSite Not Available
Site 12103
College Station, Texas 77845
United StatesSite Not Available
Site 12117
Houston, Texas 77070
United StatesSite Not Available
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