Phase
Condition
Rash
Allergy
Atopic Dermatitis
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is at least 12 years of age at the time of consent.
Subject has a clinical diagnosis of stable AD confirmed using the Hanafin and Rajkacriteria
Subject has at least a 6-month history of atopic dermatitis and had no significantflares in atopic dermatitis for at least 4 weeks before Visit 1 (screening) (information obtained from medical chart or subject's physician or directly from thesubject).
Subject must have active features of AD covering a minimum of 2% body surface area (BSA) (excluding scalp, face, genitals, palmar aspect of hands and plantar aspect offeet) at Visit 2 (baseline).
Subject has moderate AD, defined as vIGA-AD™ score of 3 ("moderate"), at Visit 2 (baseline).
Subject has an EASI score ≥ 5 at Visit 2 (baseline)
Subject has been using an emollient (except those containing urea) daily for at least 1 week prior to Visit 2 (baseline), except on visit day before the visit. Subjectagrees to continue using that emollient, daily at the same frequency, on non-treatedareas, throughout the study but not the day of visits prior to the visit scheduledtime.
Female subject of childbearing potential involved in any sexual intercourse that couldlead to her pregnancy, must have a negative serum pregnancy test at Visit 1, anegative urine pregnancy test at Visit 2 (baseline) and agree to use an approvedhighly effective contraceptive method for the entire study and up to 4 weeks followingthe final dose of study medication unless they are surgically sterile (hysterectomy,bilateral oophorectomy, or bilateral salpingectomy) or in menopausal state for atleast one year prior to screening (Visit 1)
Male subject of childbearing potential agree to use an approved highly effectivemethod of contraception through study participation for 4 weeks following the finaldose of study medication
Subject is in good general health and free of any known disease state or physicalcondition which, in the investigator's opinion, might impair evaluation of the ADbeing treated or which exposes the subject to an unacceptable risk by studyparticipation
Subject is willing and able to follow all study instructions and to attend all studyvisits
Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)/Assent Form (AF)
Parent/guardian has the ability to understand, agree to and sign the study InformedConsent Form (ICF) prior to initiation of any protocol-related procedures asapplicable; subject has the ability to give assent in the Assent Form (AF)
Informed Consent Form (ICF)/Assent Form (AF) must be obtained prior to initiation ofany protocol-related procedures.
Exclusion
Exclusion Criteria:
Subject has spontaneously improving or rapidly deteriorating AD
Subject has clinically infected AD
Subject has any signs or symptoms associated with topical AD therapy which, in theinvestigator's opinion, might impair evaluation of the AD being treated or whichexposes the subject to an unacceptable risk by study participation
Subject has any clinically significant laboratory abnormality, medical condition orphysical/vital signs abnormality that would, in the opinion of the investigator, putthe subject at undue risk or interfere with interpretation of study results
Subjects with a past history of cancer or lymphoproliferative disease within 5 yearsprior to Visit 2 (baseline) (subjects with successfully treated non-metastaticcutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ ofthe cervix are not to be excluded)
Subject is known to have immune deficiency or is immunocompromised
Subject has a known history of chronic infectious disease (e.g., hepatitis B,hepatitis C, or infection with human immunodeficiency virus)
Subject had major surgery within 8 weeks prior to Visit 2 (baseline) or has a majorsurgery planned during the study.
Topical medications, including but not limited to, topical corticosteroids,crisaborole and any other topical phosphodiesterase-4 inhibitor, calcineurininhibitors, tars, bleach, antimicrobials, medical devices and bleach bath within 2weeks prior to Visit 2 (baseline)
Subject has used any non-medicated topical product (e.g., lotions, gels, creams,ointments) in the planned treatment area 4 hours prior to Visit 2 (baseline)
Subject has used the following systemic treatments (other than biologics) that couldaffect atopic dermatitis less than 4 weeks prior to Visit 2 (baseline) (e.g.,retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine, oral/injectable corticosteroids) within 4 weeks prior toScreening. Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye andear drops containing corticosteroids are also allowed.
Subject has used any systemic antibiotics within 2 weeks prior to Visit 2 (baseline)
Subject has used hydroxyzine or diphenhydramine within 1 week prior to Visit 2 (baseline), unless on a stable dose.
Subject has used topical doxepin within 1 week prior to Visit 2 (baseline).
Subject has used topical products containing urea within 1 week prior to Visit 2 (baseline)
Subject has used or is planning to use any phototherapy (e.g., UVA/UVB therapy, orPUVA therapy), excessive natural or artificial ultraviolent radiation (e.g., sunlight,tanning beds) which, in the investigator's opinion, might affect AD within 4 weeksprior to Visit 2 (baseline)
Biologic therapies (e.g., Dupilumab) within 12 weeks or 5 half-lives prior to Visit 2 (baseline)
Subject has a history of sensitivity to any of the ingredients in the studymedications
Subject has any known concomitant dermatologic or medical condition which, in theinvestigator's opinion, might impair evaluation of the areas of AD being treated orwhich exposes the subject to an unacceptable risk by study participation (e.g.,psoriasis, rosacea, lichen planus, lichen simplex chronicus,…)
Subject is a female who is breastfeeding, pregnant, or who is planning to becomepregnant during the study.
Subject has a known history of clinically significant drug or alcohol abuse in thelast year prior to Visit 2 (baseline)
Subject has participated in a nonbiological investigational drug trial in whichadministration of an investigational study medication occurred within 4 weeks prior toVisit 2 (baseline)
Study Design
Study Description
Connect with a study center
Ralexar Investigational Site 20
Toronto, Ontario M9V4B4
CanadaSite Not Available
Ralexar Investigational Site 11
Montréal, Quebec H2K4L5
CanadaSite Not Available
Ralexar Investigational Site 10
Beverly Hills, California 90212
United StatesSite Not Available
Ralexar Investigational Site 5
Los Angeles, California 90045
United StatesSite Not Available
Ralexar Investigational Site 3
Aventura, Florida 33180
United StatesSite Not Available
Ralexar Investigational Site 2
Jacksonville, Florida 32256
United StatesSite Not Available
Ralexar Investigational Site 22
Miami, Florida 33147
United StatesSite Not Available
Ralexar Investigational Site 18
Pinellas Park, Florida 33781
United StatesSite Not Available
Ralexar Investigational Site 6
Sanford, Florida 32771
United StatesSite Not Available
Ralexar Investigational Site 13
Marietta, Georgia 30060
United StatesSite Not Available
Ralexar Investigational Site 7
Boise, Idaho 83713
United StatesSite Not Available
Ralexar Investigational Site 21
Gurnee, Illinois 60031
United StatesSite Not Available
Ralexar Investigational Site 1
Indianapolis, Indiana 46250
United StatesSite Not Available
Ralexar Investigational Site 17
Louisville, Kentucky 40202
United StatesSite Not Available
Ralexar Investigational Site 12
Las Vegas, Nevada 89177
United StatesSite Not Available
Ralexar Investigational Site 14
Beachwood, Ohio 44122
United StatesSite Not Available
Ralexar Investigational Site 8
Fairborn, Ohio 45324
United StatesSite Not Available
Ralexar Investigational Site 9
Oklahoma City, Oklahoma 73118
United StatesSite Not Available
Ralexar Investigational Site 19
Spartanburg, South Carolina 29307
United StatesSite Not Available
Ralexar Investigational Site 16
Austin, Texas 78745
United StatesSite Not Available
Ralexar Investigational Site 4
San Antonio, Texas 78213
United StatesSite Not Available
Ralexar Investigational Site 15
Seattle, Washington 98101
United StatesSite Not Available
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