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

A Double-blind, Superiority, and Randomized Controlled Trial to Evaluate the Efficacy of a Novel Cannabidiol Cream for Treatment of Atopic Dermatitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: JW-100; Drug: Eucrisa

Detailed 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®).

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Amazonas
    • Manaus, Amazonas, Brazil, 69020030
      • Centro Universitário Nilton Lins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 the following four features:

   1. Pruritus
   2. Typical morphology and distribution (e.g., flexural lichenification or linearity in adults)
   3. Chronic or chronically-relapsing eczematous/atopic dermatitis
   4. Personal or family history of atopy (i.e., asthma, allergic rhinitis, AD)
3. Subject has an area of AD (excluding the scalp) covering ≥5% and ≤20% body surface area
4. Subject has an Investigator's Static Global Assessment score of 2 or 3
5. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use a protocol approved method of birth control for the duration of the study
6. Subject is non-pregnant and non-lactating
7. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of AD or which exposes the subject to an unacceptable risk by study participation
8. Subject is willing and able to follow all study instructions and to attend all study visits
9. Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

1. Subject has, in the investigator's opinion, spontaneously improving or rapidly deteriorating 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 of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) which, in the investigator's opinion, puts the subject at undue risk by study participation 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 within four weeks prior to Visit 1
6. Subject has used any systemic AD therapy (e.g., systemic corticosteroids [including intranasal and inhaled corticosteroids at doses >2mg of prednisone or equivalent per day], 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, calcineurin inhibitors, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) on the planned treatment area within one week prior to Visit 1
9. Subject is currently using antihistamines (e.g., diphenhydramine, terfenadine) UNLESS the subject has been on a stable dose for at four weeks and agrees to continue that dose for the duration of the study
10. Subject has a history of sensitivity to any of the ingredients in the study medications
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 study conduct or evaluations
12. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JW-100; Subjects applying JW-100 cream twice daily at home (experimental group).	Other: JW-100; Cosmetic CBD cream (JW-100)
Active Comparator: EUCRISA; Subjects applying EUCRISA® (Pfizer) product twice daily at home (comparator group).	Drug: Eucrisa; Topical EUCRISA®, Pfizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate in ISGA score at day 15 with an improvement of grade 2 or greater.	The proportion of patients showing grade 2 or greater improvement using the the Investigator's Static Global Assessment (ISGA) scale.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The success rate of patients with an ISGA score of clear (0) or almost clear (1) at day 15.	The success rate of patients with an ISGA score of clear (0) or almost clear (1) at day 15.	15 days
Time to achieve success in ISGA scores 0 and 1.	Time to achieve success in ISGA scores 0 and 1.	15 days
Proportion of patients achieving improvement in the severity of the pruritus.	Improvement is defined as reaching scores 0 (none) or 1 (mild), with an improvement greater than or equal to 1 grade from baseline.	15 days
Time to improvement in pruritus (scores 0 and 1)	Time to improvement in pruritus (scores 0 and 1)	15 days
Percentage mean change from baseline in the severity of AD signs (erythema, exudation, excoriation, induration/papulation, and lichenification).	Percentage mean change from baseline in the severity of AD signs (erythema, exudation, excoriation, induration/papulation, and lichenification).	15 days

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Collaborators: Jupiter Wellness, Inc.
• Investigators: Principal Investigator: Daniel Fonseca, MD, Hospital Samel

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: JW-100-RCT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No