Last updated: December 15, 2022
Sponsor: Applied Biology, Inc.
Overall Status: Trial Not Available
Phase
3
Condition
Atopic Dermatitis
Hives (Urticaria)
Allergies & Asthma
Treatment
N/AClinical Study ID
NCT05016284
JW-100-RCT-001
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject has a clinical diagnosis of stable AD characterized by at least three of thefollowing four features:
- Pruritus
- Typical morphology and distribution (e.g., flexural lichenification or linearityin adults)
- Chronic or chronically-relapsing eczematous/atopic dermatitis
- Personal or family history of atopy (i.e., asthma, allergic rhinitis, AD)
- Subject has an area of AD (excluding the scalp) covering ≥5% and ≤20% body surfacearea
- Subject has an Investigator's Static Global Assessment score of 2 or 3
- If the subject is a woman of childbearing potential, she has a negative urinepregnancy test and agrees to use a protocol approved method of birth control for theduration of the study
- Subject is non-pregnant and non-lactating
- 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 AD or whichexposes the subject to an unacceptable risk by study participation
- 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)
Exclusion
Exclusion Criteria:
- Subject has, in the investigator's opinion, spontaneously improving or rapidlydeteriorating AD
- Subject has, in the investigator's opinion, clinically infected AD
- Subject has any signs or symptoms associated with topical AD therapy (e.g., history ofanaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes)which, in the investigator's opinion, puts the subject at undue risk by studyparticipation or interfere with the study conduct or evaluations
- Subject has used any systemic immunosuppressive or immunomodulatory therapy (e.g.,etanercept, alefacept, infliximab) with 16 weeks prior to Visit 1
- Subject has used any phototherapy (e.g., ultraviolet A, ultraviolet B) for AD withinfour weeks prior to Visit 1
- Subject has used any systemic AD therapy (e.g., systemic corticosteroids [includingintranasal and inhaled corticosteroids at doses >2mg of prednisone or equivalent perday], cyclosporine, immunosuppressants/immunomodulators, Janus Kinase inhibitors,methotrexate, cytostatics) within four weeks prior to Visit 1
- Subject has used any systemic antibiotics within two weeks prior to Visit 1
- Subject has used any topical AD therapy (e.g., corticosteroids, calcineurininhibitors, topical H1 and H2 antihistamines, topical antimicrobials, other medicatedtopical agents) on the planned treatment area within one week prior to Visit 1
- Subject is currently using antihistamines (e.g., diphenhydramine, terfenadine) UNLESSthe subject has been on a stable dose for at four weeks and agrees to continue thatdose for the duration of the study
- Subject has a history of sensitivity to any of the ingredients in the studymedications
- Subject has any concomitant medical condition which, in the investigator's opinion,might put the subject at undue risk by study participation or interfere with the studyconduct or evaluations
- Subject has participated in an investigational drug trial in which administration ofan investigational study medication occurred within 30 days prior to Visit 1.
Study Design
Study Start date:
November 24, 2022
Estimated Completion Date:
December 15, 2022
Study Description
Connect with a study center
Centro Universitário Nilton Lins
Manaus, Amazonas 69020030
BrazilSite Not Available
Corpometria Institute
Brasilia, 70390-150
BrazilSite Not Available
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