Trials Sponsors Conditions Drugs Pricing

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-100Other

Cosmetic CBD cream (JW-100)

JW-100

EucrisaDrug

Topical EUCRISA®, Pfizer

EUCRISA

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

Jupiter Wellness, Inc.
Type not reportedcollaborator
Applied Biology, Inc.
Industrylead

Study Sites (1)

Centro Universitário Nilton Lins

Manaus, Amazonas, 69020030, Brazil

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Daniel Fonseca, MD
Hospital Samel
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

JW-100

EUCRISA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

JW-100

EUCRISA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations