[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04119102":3,"trial-entities:NCT04119102":85,"trial-summary:NCT04119102":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":48,"locations":51,"central_contacts":77,"overall_officials":82,"references":83,"see_also_links":84},"NCT04119102","PTC07","Duobrii in Combination With Biologics","Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.","RECRUITING","2020-09-01","2020-04","2020-04-30","2019-10-14","Psoriasis Treatment Center of Central New Jersey","OTHER",false,"12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks","A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 weeks",[19],"Psoriasis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},25,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Duobrii","duobrii applied daily for 4 weeks followed by every other day for 4 weeks.",[34],"Open Label Duobrii",[36],{"measure":37,"description":38,"timeFrame":39},"Body surface area improvement","body surface area determined by palm method where 1 palm is equivalent to 1%","8 weeks",[],"ALL","18 Years",null,{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria:\n\n1. Male or female adult ≥ 18 years of age;\n2. Diagnosis of chronic plaque-type\n3. Psoriasis affecting 2%-10% BSA\n4. Patient is being treated with biologic therapy for a minimum of 24 weeks\n5. Able and willing to give written informed consent prior to performance of any study-related procedures\n\nExclusion Criteria:\n\n1. Psoriasis affecting ˂2% or \\>10% BSA\n2. Patient not receiving a biologic agent, or receiving biologic agent \\\u003C24weeks\n3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.\n4. Has previously used DUOBRII",[49,50],"ADULT","OLDER_ADULT",[52],{"facility":13,"status":8,"city":53,"state":54,"zip":55,"country":56,"contacts":57,"geoPoint":74},"East Windsor","New Jersey","08520","United States",[58,64,67,70,72],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Elise Nelson","CONTACT","609-443-4500","1402","enelson@windsordermatology.com",{"name":65,"role":66},"Jerry Bagel, MD","PRINCIPAL_INVESTIGATOR",{"name":68,"role":69},"Brian Keegan, MD, PhD","SUB_INVESTIGATOR",{"name":71,"role":69},"David Nieves, MD",{"name":73,"role":69},"Alexa Hetzel, PA-C",{"lat":75,"lon":76},40.268,-74.54043,[78,81],{"name":65,"role":60,"phone":79,"email":80},"6094434500","dreamacres1@aol.com",{"name":59,"role":60,"phone":79,"email":63},[],[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[19],[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is a single-center pilot study with 25 participants. The phase of the study is not specified.","completed","Duobrii with Biologics for Psoriasis","This study is looking at how well Duobrii, a topical medication, works when added to your current biologic therapy for psoriasis. You might be able to join if you are an adult with chronic plaque-type psoriasis affecting 2% to 10% of your body, and you've been on a biologic therapy for at least 24 weeks. The study wants to see if Duobrii improves the amount of body surface area (BSA) affected by psoriasis after 8 weeks. The current status of this study is unclear, and it plans to enroll 25 participants.","The primary endpoint for improvement is measured at 8 weeks.",91,"You would apply Duobrii daily for 4 weeks, then every other day for another 4 weeks. The study assesses your body surface area improvement at 8 weeks.","Not stated in the trial record.",[31],"v2"]