Phase
Condition
Rosacea
Skin Infections/disorders
Eczema (Atopic Dermatitis - Pediatric)
Treatment
Tapinarof cream, 1%
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Roll-over Subjects Only:
Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study,DMVT-505-3102 study, or DMVT-505-2104 study).
Must not be pregnant at Baseline
For Direct-Enrolling Subjects Only:
Male and female subjects ages 2 years to < 18 years at the time of consent withclinical diagnosis of AD
Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screeningand Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 atScreening and Baseline (pre-randomization) regardless of BSA. Subjects must havescreened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/orvIGA-AD™ eligibility criteria.
AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
Must not be pregnant at Screening or Baseline
For All Subjects:
Female subjects of childbearing potential who are engaging in sexual activity thatcould lead to pregnancy should use acceptable birth control methods
Subject, subject's parent, or legal representative must be capable of giving writteninformed consent/assent
Exclusion
Exclusion Criteria:
For Rollover Subjects Only:
Subjects who were not receiving study drug at the time of the last visit in thepivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
Used a prohibited concomitant product or procedure to treat AD during the pivotalstudy.
Had an SAE that was related to treatment or experienced an AE that led to permanentdiscontinuation of treatment in the pivotal study.
Pregnant females
For Direct-Enrolling Subjects:
Immunocompromised at screening
Chronic or acute systemic or superficial infection requiring treatment with systemicantibacterials or antifungals within one week prior to baseline visit
Significant dermatological or inflammatory condition other than AD that, in theInvestigator's opinion, would make it difficult to interpret data or assessmentsduring the study
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upperlimit of normal (ULN).
Screening total bilirubin > 1.5x ULN
Current or chronic history of liver disease
Current or history of cancer within 5 years except for adequately treated cutaneousbasal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Subjects who would not be considered suitable for topical therapy
Use of any prohibited medication or procedure within the indicated period before thebaseline visit including other investigational product within 30 days or 5half-lives of the investigational product (whichever is longer)
History of or ongoing serious illness or medical, physical, or psychiatriccondition(s) that, in the Investigator's opinion, may interfere with the subject'sparticipation in the study, interpretation of results, or ability to understand andgive informed consent.
Pregnant or lactating females
History of sensitivity to the study medications, or components thereof or a historyof drug or other allergy that, in the opinion of the Investigator or MedicalMonitor, contraindicates their participation
Previous known participation in a clinical study with tapinarof (previously known asGSK2894512 and WBI-1001)
Study Design
Study Description
Connect with a study center
Dermavant Investigative Site
Calgary, Alberta T3A 2N1
CanadaSite Not Available
Dermavant Clinical Site
Surrey, British Columbia V3R 6A7
CanadaActive - Recruiting
Dermavant Investigative Site
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Dermavant Investigative Site
Winnipeg, Manitoba R3M 3Z4
CanadaSite Not Available
Dermavant Clinical Site
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
Dermavant Investigative Site
Barrie, Ontario L4M 7G1
CanadaSite Not Available
Dermavant Investigative Site
Cobourg, Ontario K9A 0Z4
CanadaSite Not Available
Dermavant Clinical Site
Oakville, Ontario L6J 7W5
CanadaActive - Recruiting
Dermavant Investigative Site
Oakville, Ontario L6J 7W5
CanadaSite Not Available
Dermavant Clinical Site
Ottawa, Ontario K2C 3N2
CanadaActive - Recruiting
Dermavant Investigative Site
Ottawa, Ontario K2C 3N2
CanadaSite Not Available
Dermavant Clinical Site
Waterloo, Ontario N2J 7G1
CanadaActive - Recruiting
Dermavant Investigative Site
Waterloo, Ontario N2J 7G1
CanadaSite Not Available
Dermavant Clinical Site
Windsor, Ontario N8W 1E6
CanadaActive - Recruiting
Dermavant Investigative Site
Windsor, Ontario N8W 1E6
CanadaSite Not Available
Dermavant Investigative Site
Montréal, Quebec H2X 2V1
CanadaSite Not Available
Dermavant Clinical Site
Birmingham, Alabama 35244
United StatesActive - Recruiting
Dermavant Investigative Site
Birmingham, Alabama 35244
United StatesSite Not Available
Dermavant Clinical Site
Phoenix, Arizona 85032
United StatesActive - Recruiting
Dermavant Investigative Site
Phoenix, Arizona 85032
United StatesSite Not Available
Dermavant Clinical Site
Scottsdale, Arizona 85260
United StatesActive - Recruiting
Dermavant Investigative Site
Scottsdale, Arizona 85255
United StatesSite Not Available
Dermavant Clinical Site
Bryant, Arkansas 72022
United StatesActive - Recruiting
Dermavant Investigative Site
Bryant, Arkansas 72022
United StatesSite Not Available
Dermavant Clinical Site
Fort Smith, Arkansas 72916
United StatesActive - Recruiting
Dermavant Investigative Site
Fort Smith, Arkansas 72916
United StatesSite Not Available
Dermavant Clinical Site
Cerritos, California 90702
United StatesActive - Recruiting
Dermavant Investigative Site
Cerritos, California 90702
United StatesSite Not Available
Dermavant Clinical Site
Fountain Valley, California 92708
United StatesActive - Recruiting
Dermavant Investigative Site
Fountain Valley, California 92708
United StatesSite Not Available
Dermavant Clinical Site
Fremont, California 94538
United StatesActive - Recruiting
Dermavant Investigative Site
Fremont, California 94538
United StatesSite Not Available
Dermavant Clinical Site
Huntington Beach, California 92647
United StatesActive - Recruiting
Dermavant Investigative Site
Huntington Beach, California 92647
United StatesSite Not Available
Dermavant Clinical Site
Inglewood, California 90301
United StatesActive - Recruiting
Dermavant Investigative Site
Inglewood, California 90301
United StatesSite Not Available
Dermavant Clinical Site
Lancaster, California 93534
United StatesActive - Recruiting
Dermavant Investigative Site
Lancaster, California 93534
United StatesSite Not Available
Dermavant Investigative Site
Long Beach, California 90806
United StatesSite Not Available
Dermavant Clinical Site
Los Angeles, California 90045
United StatesActive - Recruiting
Dermavant Investigative Site
Los Angeles, California 90033
United StatesSite Not Available
Dermavant Clinical Site
Mission Viejo, California 92691
United StatesActive - Recruiting
Dermavant Investigative Site
Mission Viejo, California 92691
United StatesSite Not Available
Dermavant Investigative Site
Sacramento, California 95815
United StatesSite Not Available
Dermavant Investigative Site
San Diego, California 92123
United StatesSite Not Available
Dermavant Investigative Site
San Francisco, California 94115
United StatesSite Not Available
Dermavant Clinical Site
Santa Ana, California 92701
United StatesActive - Recruiting
Dermavant Investigative Site
Santa Ana, California 92701
United StatesSite Not Available
Dermavant Clinical Site
Santa Monica, California 90404
United StatesActive - Recruiting
Dermavant Investigative Site
Santa Monica, California 90404
United StatesSite Not Available
Dermavant Clinical Site
Thousand Oaks, California 91320
United StatesActive - Recruiting
Dermavant Investigative Site
Thousand Oaks, California 91320
United StatesSite Not Available
Dermavant Investigative Site
Thornton, Colorado 80112
United StatesSite Not Available
Dermavant Investigative Site
Washington, District of Columbia 20037
United StatesSite Not Available
Dermavant Clinical Site
Boca Raton, Florida 33486
United StatesActive - Recruiting
Dermavant Investigative Site
Boca Raton, Florida 33428
United StatesSite Not Available
Dermavant Investigative Site
Brandon, Florida 33511
United StatesSite Not Available
Dermavant Clinical Site
Coral Gables, Florida 33146
United StatesActive - Recruiting
Dermavant Investigative Site
Coral Gables, Florida 33146
United StatesSite Not Available
Dermavant Clinical Site
Delray Beach, Florida 33484
United StatesActive - Recruiting
Dermavant Investigative Site
Delray Beach, Florida 33484
United StatesSite Not Available
Dermavant Clinical Site
Hialeah, Florida 33016
United StatesActive - Recruiting
Dermavant Investigative Site
Hialeah, Florida 33016
United StatesSite Not Available
Dermavant Clinical Site
Jacksonville, Florida 32256
United StatesActive - Recruiting
Dermavant Investigative Site
Jacksonville, Florida 32256
United StatesSite Not Available
Dermavant Clinical Site
Margate, Florida 33063
United StatesActive - Recruiting
Dermavant Investigative Site
Margate, Florida 33063
United StatesSite Not Available
Dermavant Clinical Site
Miami, Florida 33165
United StatesActive - Recruiting
Dermavant Investigative Site
Miami, Florida 33173
United StatesSite Not Available
Dermavant Clinical Site
Miami Lakes, Florida 33014
United StatesActive - Recruiting
Dermavant Investigative Site
Miami Lakes, Florida 33014
United StatesSite Not Available
Dermavant Clinical Site
Orlando, Florida 32801
United StatesActive - Recruiting
Dermavant Investigative Site
Orlando, Florida 32801
United StatesSite Not Available
Dermavant Clinical Site
Pinellas Park, Florida 33781
United StatesActive - Recruiting
Dermavant Investigative Site
Pinellas Park, Florida 33781
United StatesSite Not Available
Dermavant Investigative Site
Sweetwater, Florida 33172
United StatesSite Not Available
Dermavant Clinical Site
Tampa, Florida 33607
United StatesActive - Recruiting
Dermavant Investigative Site
Tampa, Florida 33607
United StatesSite Not Available
Dermavant Investigative Site
Marietta, Georgia 30060
United StatesSite Not Available
Dermavant Clinical Site
Sandy Springs, Georgia 30328
United StatesActive - Recruiting
Dermavant Investigative Site
Sandy Springs, Georgia 30328
United StatesSite Not Available
Dermavant Clinical Site
Savannah, Georgia 31406
United StatesActive - Recruiting
Dermavant Investigative Site
Savannah, Georgia 31406
United StatesSite Not Available
Dermavant Investigative Site
Snellville, Georgia 30078
United StatesSite Not Available
Dermavant Investigative Site
Chicago, Illinois 60611
United StatesSite Not Available
Dermavant Clinical Site
Evansville, Indiana 47715
United StatesActive - Recruiting
Dermavant Investigative Site
Evansville, Indiana 47715
United StatesSite Not Available
Dermavant Clinical Site
Plainfield, Indiana 46168
United StatesActive - Recruiting
Dermavant Investigative Site
Plainfield, Indiana 46168
United StatesSite Not Available
Dermavant Investigative Site
Overland Park, Kansas 66210
United StatesSite Not Available
Dermavant Clinical Site
Lexington, Kentucky 40517
United StatesActive - Recruiting
Dermavant Investigative Site
Lexington, Kentucky 40517
United StatesSite Not Available
Dermavant Clinical Site
Louisville, Kentucky 40217
United StatesActive - Recruiting
Dermavant Investigative Site
Louisville, Kentucky 40217
United StatesSite Not Available
Dermavant Investigative Site
Owensboro, Kentucky 42301
United StatesSite Not Available
Dermavant Clinical Site
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
Dermavant Investigative Site
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Dermavant Clinical Site
Covington, Louisiana 70433
United StatesActive - Recruiting
Dermavant Investigative Site
Covington, Louisiana 70433
United StatesSite Not Available
Dermavant Clinical Site
Monroe, Louisiana 71201
United StatesActive - Recruiting
Dermavant Investigative Site
Monroe, Louisiana 71201
United StatesSite Not Available
Dermavant Clinical Site
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Dermavant Investigative Site
New Orleans, Louisiana 70115
United StatesSite Not Available
Dermavant Clinical Site
Largo, Maryland 20774
United StatesActive - Recruiting
Dermavant Investigative Site
Largo, Maryland 20774
United StatesSite Not Available
Dermavant Clinical Site
Rockville, Maryland 20850
United StatesActive - Recruiting
Dermavant Investigative Site
Rockville, Maryland 20850
United StatesSite Not Available
Dermavant Clinical Site
Bay City, Michigan 48706
United StatesActive - Recruiting
Dermavant Investigative Site
Bay City, Michigan 48706
United StatesSite Not Available
Dermavant Clinical Site
Clarkston, Michigan 48346
United StatesActive - Recruiting
Dermavant Investigative Site
Clarkston, Michigan 48346
United StatesSite Not Available
Dermavant Clinical Site
Warren, Michigan 48088
United StatesActive - Recruiting
Dermavant Investigative Site
Warren, Michigan 48088
United StatesSite Not Available
Dermavant Clinical Site
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Dermavant Investigative Site
Ypsilanti, Michigan 48197
United StatesSite Not Available
Dermavant Clinical Site
New Brighton, Minnesota 55112
United StatesActive - Recruiting
Dermavant Investigative Site
New Brighton, Minnesota 55112
United StatesSite Not Available
Dermavant Clinical Site
Missoula, Montana 59808
United StatesActive - Recruiting
Dermavant Investigative Site
Missoula, Montana 59808
United StatesSite Not Available
Dermavant Clinical Site
Omaha, Nebraska 68144
United StatesActive - Recruiting
Dermavant Investigative Site
Omaha, Nebraska 68144
United StatesSite Not Available
Dermavant Investigative Site
East Windsor, New Jersey 08520
United StatesSite Not Available
Dermavant Clinical Site
Garden City, New York 11530
United StatesActive - Recruiting
Dermavant Investigative Site
Garden City, New York 11530
United StatesSite Not Available
Dermavant Investigative Site
New York, New York 10075
United StatesSite Not Available
Dermavant Investigative Site
Charlotte, North Carolina 28277
United StatesSite Not Available
Dermavant Clinical Site
Bexley, Ohio 43209
United StatesActive - Recruiting
Dermavant Investigative Site
Bexley, Ohio 43209
United StatesSite Not Available
Dermavant Investigative Site
Cleveland, Ohio 44106
United StatesSite Not Available
Dermavant Clinical Site
Dayton, Ohio 45414
United StatesActive - Recruiting
Dermavant Investigative Site
Dayton, Ohio 45414
United StatesSite Not Available
Dermavant Investigative Site
Mason, Ohio 45040
United StatesSite Not Available
Dermavant Clinical Site
Mayfield Heights, Ohio 44124
United StatesActive - Recruiting
Dermavant Investigative Site
Mayfield Heights, Ohio 44124
United StatesSite Not Available
Dermavant Clinical Site
Norman, Oklahoma 73071
United StatesActive - Recruiting
Dermavant Investigative Site
Norman, Oklahoma 73071
United StatesSite Not Available
Dermavant Clinical Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Dermavant Investigative Site
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Dermavant Clinical Site
Tulsa, Oklahoma 74114
United StatesActive - Recruiting
Dermavant Investigative Site
Tulsa, Oklahoma 74114
United StatesSite Not Available
Dermavant Investigative Site
Medford, Oregon 97504
United StatesSite Not Available
Dermavant Clinical Site
Portland, Oregon 97223
United StatesActive - Recruiting
Dermavant Investigative Site
Portland, Oregon 97210
United StatesSite Not Available
Dermavant Clinical Site
Anderson, South Carolina 29621
United StatesActive - Recruiting
Dermavant Investigative Site
Anderson, South Carolina 29621
United StatesSite Not Available
Dermavant Clinical Site
Greenville, South Carolina 29615
United StatesActive - Recruiting
Dermavant lnvestigative Site
Greenville, South Carolina 29615
United StatesSite Not Available
Dermavant Clinical Site
Mount Pleasant, South Carolina 29445
United StatesActive - Recruiting
Dermavant Investigative Site
Mount Pleasant, South Carolina 29445
United StatesSite Not Available
Dermavant Investigative Site
North Charleston, South Carolina 29420
United StatesSite Not Available
Dermavant Clinical Site
Spartanburg, South Carolina 29303
United StatesActive - Recruiting
Dermavant Investigative Site
Spartanburg, South Carolina 29303
United StatesSite Not Available
Dermavant Clinical Site
Knoxville, Tennessee 37909
United StatesActive - Recruiting
Dermavant Investigative Site
Knoxville, Tennessee 37909
United StatesSite Not Available
Dermavant Clinical Site
Memphis, Tennessee 38119
United StatesActive - Recruiting
Dermavant Investigative Site
Memphis, Tennessee 38119
United StatesSite Not Available
Dermavant Investigative Site
Bellaire, Texas 77401
United StatesSite Not Available
Dermavant Clinical Site
Cypress, Texas 77433
United StatesActive - Recruiting
Dermavant Investigative Site
Cypress, Texas 77433
United StatesSite Not Available
Dermavant Investigative Site
Dallas, Texas 75230
United StatesSite Not Available
Dermavant Clinical Site
Dripping Springs, Texas 78620
United StatesActive - Recruiting
Dermavant Investigative Site
Dripping Springs, Texas 78620
United StatesSite Not Available
Dermavant Investigative Site
Grapevine, Texas 76051
United StatesSite Not Available
Dermavant Investigative Site
Houston, Texas 77004
United StatesSite Not Available
Dermavant Clinical Site
San Antonio, Texas 78229
United StatesActive - Recruiting
Dermavant Investigative Site
San Antonio, Texas 78213
United StatesSite Not Available
Dermavant Clinical Site
Sugar Land, Texas 77479
United StatesActive - Recruiting
Dermavant Investigative Site
Sugar Land, Texas 77479
United StatesSite Not Available
Dermavant Investigative Site
Webster, Texas 77598
United StatesSite Not Available
Dermavant Investigative Site
Richmond, Virginia 23226
United StatesSite Not Available
Dermavant Clinical Site
Spokane, Washington 99202
United StatesActive - Recruiting
Dermavant Investigative Site
Spokane, Washington 99202
United StatesSite Not Available
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