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

Description

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.

Conditions

Atopic Dermatitis

Study Overview

Study Details

Study overview

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.

Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Sacramento

Integrative Skin Science and Research, Sacramento, California, United States, 95815

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Individuals who have a known allergy to isosorbide diesters, coconut oil, or sunflower seed oil
  • * Individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body.
  • * Individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo 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 of the investigator. Systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. Subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. Subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period.
  • * Subjects with a diagnosis of Scabies.
  • * Pregnant women
  • * Prisoners

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Integrative Skin Science and Research,

Study Record Dates

2024-03-31