Last updated: April 12, 2023
Sponsor: Integrative Skin Science and Research
Overall Status: Active - Recruiting
Phase
N/A
Condition
Allergy
Scalp Disorders
Eczema (Atopic Dermatitis - Pediatric)
Treatment
N/AClinical Study ID
NCT05688735
IDEAS_PEDS_AD
Ages 2-17 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Males and females ages 2-17 years old at the time of consent.
- Clinical diagnosis of active atopic dermatitis
- vIGA-AD (validated Investigator Global Assessment-Atopic Dermatitis) score of "mild" (2) or "moderate" (3) at Baseline
- EASI (Eczema Area and Severity Index) score of >/= 5 at Baseline
Exclusion
Exclusion Criteria:
- Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflowerseed oil
- Individuals who have solely hand and/or foot eczema without evidence of eczemaanywhere else on their body.
- Individuals who have been on topical calcineurin inhibitors or crisaborole to thepredetermined areas within two weeks of initiation of participation or unwilling toundergo a washout period.
- Subjects with an ongoing secondary infection of the skin.
- Subjects who are on systemic therapy or who need systemic therapy at the discretion ofthe investigator. Systemic therapies include cyclosporine, systemic steroids,methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemicsteroids, or methotrexate in the month prior to initiation of study intervention orare unwilling to undergo a washout period. Subjects who have been on dupilumab in twomonths prior to initiation of study intervention or are unwilling to undergo a washoutperiod.
- Subjects with a diagnosis of Scabies.
- Pregnant women
- Prisoners
Study Design
Total Participants: 40
Study Start date:
April 20, 2023
Estimated Completion Date:
March 31, 2024
Connect with a study center
Integrative Skin Science and Research
Sacramento, California 95815
United StatesActive - Recruiting
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