Atopic DermatitisPhase 3NCT05016284
Comparison of JW-100 and EUCRISA for the Treatment of Atopic Dermatitis
A Phase 3 study testing JW-100 and Eucrisa in people with Atopic Dermatitis, run by Applied Biology, Inc. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- JW-100 and Eucrisa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Nov 2022to 15 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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®).
- Conditions
- Atopic Dermatitis
- Being tested
- JW-100, Eucrisa
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JW-100Other
Cosmetic CBD cream (JW-100)
EucrisaDrug
Topical EUCRISA®, Pfizer
| Study group | Role | What they receive |
|---|---|---|
| JW-100 | Experimental | Subjects applying JW-100 cream twice daily at home (experimental group). Receives: Other: JW-100 |
| EUCRISA | Active comparator | Subjects applying EUCRISA® (Pfizer) product twice daily at home (comparator group). Receives: Drug: Eucrisa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (5)
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.
Measured: 15 days
Time to achieve success in ISGA scores 0 and 1.
Time to achieve success in ISGA scores 0 and 1.
Measured: 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.
Measured: 15 days
Time to improvement in pruritus (scores 0 and 1)
Time to improvement in pruritus (scores 0 and 1)
Measured: 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).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start24 Nov 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jupiter Wellness, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel Fonseca, MD, Principal investigator, Hospital Samel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016284
- Sponsor's protocol ID
- JW-100-RCT-001
- Status last verified
- Nov 2022
- First submitted
- 17 Aug 2021
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Superiority, and Randomized Controlled Trial to Evaluate the Efficacy of a Novel Cannabidiol Cream for Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05016284
- Acronym / sponsor ID
- JW-100-RCT-001
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jupiter Wellness, Inc.
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JW-100 | Experimental | Other: JW-100Subjects applying JW-100 cream twice daily at home (experimental group). |
| EUCRISA | Active comparator | Drug: EucrisaSubjects applying EUCRISA® (Pfizer) product twice daily at home (comparator group). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JW-100Cosmetic CBD cream (JW-100) | Other | JW-100 |
| EucrisaTopical EUCRISA®, Pfizer | Drug | EUCRISA |
Primary outcome
The success rate in ISGA score at day 15 with an improvement of grade 2 or greater.
Time frame: 15 days
The proportion of patients showing grade 2 or greater improvement using the the Investigator's Static Global Assessment (ISGA) scale.
5 secondary outcomes
The success rate of patients with an ISGA score of clear (0) or almost clear (1) at day 15.
Time frame: 15 days
Time to achieve success in ISGA scores 0 and 1.
Time frame: 15 days
Proportion of patients achieving improvement in the severity of the pruritus.
Time frame: 15 days
Time to improvement in pruritus (scores 0 and 1)
Time frame: 15 days
Percentage mean change from baseline in the severity of AD signs (erythema, exudation, excoriation, induration/papulation, and lichenification).
Time frame: 15 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No. Data will not be shared
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fonseca, MD principal investigator
Hospital Samel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JW-100 and Eucrisa in people with Atopic Dermatitis, run by Applied Biology, Inc. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate in ISGA score at day 15 with an improvement of grade 2 or greater. (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.