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Cream IP for Atopic Dermatitis

N/A

Waitlist Available

Led By Laura M Brooks, M.D.

Research Sponsored by Johnson & Johnson Consumer Inc. (J&JCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 3, 7 and week 4

Awards & highlights

Study Summary

This trial is testing an investigational cream to see if it is effective and safe to use in babies, toddlers, and children with mild to moderate atopic dermatitis.

Eligible Conditions

Atopic Dermatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 3, 7 and week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 3, 7 and week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 3, 7 and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Atopic Dermatitis Severity Index (ADSI) After 4 Weeks of Product Use

Change From Baseline in Eczema Area Severity Index (EASI) After 4 Weeks of Product Use

Secondary outcome measures

Change From Baseline in ADSI

Change From Baseline in Brief Infant Sleep Questionnaire-Revised (BISQ-R) Scale Score

Change From Baseline in Caregiver Itch Assessment Score

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Wash and Cream Investigational Product (IP)Experimental Treatment2 Interventions

Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks. Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.

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Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor

52 Previous Clinical Trials

5,463 Total Patients Enrolled

Laura M Brooks, M.D.Principal InvestigatorThe Education & Research Foundation, Inc.

Laura M Brooks, MDPrincipal InvestigatorThe Education & Research Foundation, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include participants of at least twenty years in age?

"This clinical trial specifies that participants must be between 3 Months and 72 Months old, in accordance with the eligibility criteria."

Answered by AI

Who is the ideal participant for this clinical investigation?

"Entry into this research requires a diagnosis of dermatitis along with an age between 3 Months and 72 Months. A total of 20 people will be accepted for this study."

Answered by AI

Are there opportunities to enroll in this trial at the present moment?

"Clinicaltrials.gov states that this specific research trial is no longer enrolling patients. The investigation was initially published on September 26th 2022 and has since been edited, with the most recent update taking place October 3rd of the same year. However, there are presently 220 other clinical trials actively in search of participants."

Answered by AI

Can you explain the primary objective of this clinical experiment?

"The primary evaluation criteria of this experiment, from Baseline to Week 4, is the alteration in Eczema Area Severity Index (EASI) after four weeks of product use. Secondary endpoints include assessing the amount of scratching/itching experienced by a caretaker through Parent participant’s assessment on a scale ranging 1-4; measuring EASI with composite scoring system index for erythema, edema/induration/papulation, excoriations and lichenification; and reporting TEWL measurement difference between lesional site and an adjacent non-lesional site using DermaLab TEWL"

Answered by AI

Recent research and studies

Dermatologic ClinicsJournal

Atopic Dermatitis: An Update and Review of the Literature

Lipozenčić, Jasna, and Ronni Wolf. 2007. “Atopic Dermatitis: An Update and Review of the Literature”. Dermatologic Clinics. Elsevier BV. doi:10.1016/j.det.2007.06.009.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Experimental DermatologyJournal

The Eczema Area and Severity Index (EASI): Assessment of Reliability in Atopic Dermatitis

Hanifin, J. M., M. Thurston, M. Omoto, R. Cherill, S. J. Tofte, M. Graeber, and The Easi Evaluator Group. 2001. “The Eczema Area and Severity Index (EASI): Assessment of Reliability in Atopic Dermatitis”. Experimental Dermatology. Wiley. doi:10.1034/j.1600-0625.2001.100102.x.

Genome ResearchJournal