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

NCT05016284 | Withdrawn Phase 3

• 1 other identifier: JW-100-RCT-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  15 days

• Proportion of patients achieving improvement in the severity of the pruritus.

  15 days

• 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).

  15 days

Study Arms (2)

JW-100

EXPERIMENTAL

Subjects applying JW-100 cream twice daily at home (experimental group).

Other: JW-100

EUCRISA

ACTIVE COMPARATOR

Subjects applying EUCRISA® (Pfizer) product twice daily at home (comparator group).

Drug: Eucrisa

Interventions

JW-100 OTHER

Cosmetic CBD cream (JW-100)

JW-100

Eucrisa DRUG

Topical EUCRISA®, Pfizer

EUCRISA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age.
• Subject has a clinical diagnosis of stable AD characterized by at least three of the following four features:
• Pruritus
• Typical morphology and distribution (e.g., flexural lichenification or linearity in 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 surface area
• 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 urine pregnancy test and agrees to use a protocol approved method of birth control for the duration of the study
• Subject is non-pregnant and non-lactating
• 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
• Subject is willing and able to follow all study instructions and to attend all study visits
• Subject is able to comprehend and willing to sign an Informed Consent Form (ICF)

You may not qualify if:

• Subject has, in the investigator's opinion, spontaneously improving or rapidly deteriorating 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 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
• 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 within four weeks prior to Visit 1
• 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
• Subject has used any systemic antibiotics within two weeks prior to Visit 1
• 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
• 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
• Subject has a history of sensitivity to any of the ingredients in the study medications
• 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
• Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Jupiter Wellness, Inc.: collaborator

Study Sites (1)

Centro Universitário Nilton Lins

Manaus, Amazonas, 69020030, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Daniel Fonseca, MD

  Hospital Samel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: November 24, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)