Comparison of JW-100 and EUCRISA for the Treatment of Atopic Dermatitis

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/A

Clinical Study ID

NCT05016284
JW-100-RCT-001
  • Ages 18-70
  • All Genders

Study Summary

To compare the efficacy of a JW-100 cream with active control (commercially available as EUCRISA®, Pfizer) for the treatment of atopic dermatitis (AD) in adult patients with mild to moderate AD measured with the Investigator's Static Global Assessment (ISGA) scale.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is at least 18 years of age.
  2. Subject has a clinical diagnosis of stable AD characterized by at least three of thefollowing four features:
  3. Pruritus
  4. Typical morphology and distribution (e.g., flexural lichenification or linearityin adults)
  5. Chronic or chronically-relapsing eczematous/atopic dermatitis
  6. Personal or family history of atopy (i.e., asthma, allergic rhinitis, AD)
  7. Subject has an area of AD (excluding the scalp) covering ≥5% and ≤20% body surfacearea
  8. Subject has an Investigator's Static Global Assessment score of 2 or 3
  9. 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
  10. Subject is non-pregnant and non-lactating
  11. 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
  12. Subject is willing and able to follow all study instructions and to attend all studyvisits
  13. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion

Exclusion Criteria:

  1. Subject has, in the investigator's opinion, spontaneously improving or rapidlydeteriorating AD
  2. Subject has, in the investigator's opinion, clinically infected AD
  3. 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
  4. Subject has used any systemic immunosuppressive or immunomodulatory therapy (e.g.,etanercept, alefacept, infliximab) with 16 weeks prior to Visit 1
  5. Subject has used any phototherapy (e.g., ultraviolet A, ultraviolet B) for AD withinfour weeks prior to Visit 1
  6. 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
  7. Subject has used any systemic antibiotics within two weeks prior to Visit 1
  8. 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
  9. 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
  10. Subject has a history of sensitivity to any of the ingredients in the studymedications
  11. 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
  12. 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

Atopic dermatitis (AD) is one of the most common inflammatory skin diseases, affecting 13% of children and approximately 7% of adults in the United States. AD is often stimulated by a cascade of inflammatory events; thus, corticosteroids, immunosuppressive drugs, and antihistamines are often prescribed. Many industrialized countries have legalized botanical cannabis and its extracts for medical purposes. The most clinically relevant components of botanical cannabis are the cannabinoid agents delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and the noncannabinoids compounds, terpenoids, and flavonoids. The aim of this study is to explore the efficacy of a novel cannabidiol cream in the treatment of atopic dermatitis in comparison with a commercially available product from Pfizer (EUCRISA®).

Connect with a study center

  • Centro Universitário Nilton Lins

    Manaus, Amazonas 69020030
    Brazil

    Site Not Available

  • Corpometria Institute

    Brasilia, 70390-150
    Brazil

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.