Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

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/A

Clinical Study ID

NCT05688735
IDEAS_PEDS_AD
  • Ages 2-17
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this study is to compare coconut oil and sunflower seed oil derived isosorbide disesters and colloidal oatmeal, and observe their effect on pediatric atopic dermatitis among males and females aged 2-17.

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 States

    Active - Recruiting

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