Psoriasis Clinical Trial
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Summary
This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety follow-up period.
Full Description
At the completion of the Week-12 visit of the pivotal study (Baseline [Day 1] in this study), all eligible subjects will be offered enrollment in the long-term extension study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 44 weeks.
Eligibility Criteria
Inclusion Criteria:
Completed the 12-week treatment period in 1 of the 2 parent studies (Study DMVT-505-3001 or Study DMVT-505-3002);
Male and female subjects
Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance while on the study, and for at least 4 weeks after the last exposure to study treatment
Capable of giving written informed consent
Exclusion Criteria:
Used a prohibited concomitant product or procedure to treat psoriasis during parent study
Had a serious adverse event (SAE) that was potentially related to treatment or experienced an adverse event (AE) that led to permanent discontinuation of treatment in the parent study
History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's completion of the study
Known hypersensitivity to tapinarof
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There are 100 Locations for this study
Birmingham Alabama, 35205, United States
Phoenix Arizona, 85032, United States
Bryant Arkansas, 72022, United States
Fort Smith Arkansas, 72916, United States
Fountain Valley California, 92708, United States
Fremont California, 94538, United States
Fresno California, 93720, United States
Los Angeles California, 90033, United States
Los Angeles California, 90045, United States
Northridge California, 91324, United States
Oceanside California, 92056, United States
San Diego California, 92123, United States
Santa Ana California, 92701, United States
Santa Monica California, 90404, United States
Denver Colorado, 80210, United States
Cromwell Connecticut, 06416, United States
Boca Raton Florida, 33431, United States
Boynton Beach Florida, 33437, United States
Hialeah Florida, 33016, United States
Margate Florida, 33063, United States
Miami Florida, 33144, United States
Miramar Florida, 33027, United States
Boise Idaho, 83713, United States
Rolling Meadows Illinois, 60008, United States
Evansville Indiana, 47714, United States
Indianapolis Indiana, 46250, United States
New Albany Indiana, 47150, United States
Plainfield Indiana, 46168, United States
Overland Park Kansas, 66215, United States
Louisville Kentucky, 40217, United States
Owensboro Kentucky, 42303, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70115, United States
Rockville Maryland, 20850, United States
Boston Massachusetts, 02115, United States
Bay City Michigan, 48706, United States
Clarkston Michigan, 48346, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 48202, United States
Fort Gratiot Michigan, 48059, United States
Warren Michigan, 48088, United States
Fridley Minnesota, 55432, United States
Saint Joseph Missouri, 64506, United States
Omaha Nebraska, 68144, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89148, United States
East Windsor New Jersey, 08520, United States
Hackensack New Jersey, 07601, United States
Verona New Jersey, 07044, United States
Brooklyn New York, 11203, United States
Kew Gardens New York, 11374, United States
New York New York, 10029, United States
Rochester New York, 14623, United States
Stony Brook New York, 11790, United States
Watertown New York, 13601, United States
Cary North Carolina, 27518, United States
High Point North Carolina, 27262, United States
Wilmington North Carolina, 28405, United States
Winston-Salem North Carolina, 27157, United States
Beachwood Ohio, 44122, United States
Bexley Ohio, 43209, United States
Norman Oklahoma, 73071, United States
Norman Oklahoma, 73072, United States
Norman Oklahoma, 73072, United States
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Portland Oregon, 97223, United States
Pittsburgh Pennsylvania, 15213, United States
Johnston Rhode Island, 02919, United States
Charleston South Carolina, 29407, United States
Nashville Tennessee, 37215, United States
Arlington Texas, 76011, United States
Bellaire Texas, 77401, United States
College Station Texas, 77845, United States
Dripping Springs Texas, 78620, United States
Houston Texas, 77004, United States
Houston Texas, 77030, United States
Pflugerville Texas, 78660, United States
Plano Texas, 75024, United States
San Antonio Texas, 78213, United States
San Antonio Texas, 78229, United States
Webster Texas, 77598, United States
West Jordan Utah, 84088, United States
Norfolk Virginia, 23502, United States
Spokane Washington, 99202, United States
Edmonton Alberta, T5K 1, Canada
Surrey Bristish Columbia, V3V 0, Canada
Surrey British Columbia, V3R 6, Canada
Ajax Ontario, L1S 7, Canada
Burlington Ontario, L7L 6, Canada
Cobourg Ontario, K9A 0, Canada
Etobicoke Ontario, M8X 1, Canada
Hamilton Ontario, L8N 1, Canada
Hamilton Ontario, L8S 1, Canada
Markham Ontario, L3P 1, Canada
Markham Ontario, L3P 1, Canada
North Bay Ontario, P1B 3, Canada
Oakville Ontario, L6J 7, Canada
Ottawa Ontario, K2C 3, Canada
Richmond Hill Ontario, L4C 9, Canada
Toronto Ontario, M3H 5, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 5, Canada
Montréal Quebec, H2X 2, Canada
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