RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-20

Study Completion:2024-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05688735

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.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Raja Sivamani, MD

CONTACT

(916) 750-2463

raja.sivamani@integrativeskinresearch.com

Study Locations (Sites)

Integrative Skin Science and Research

Sacramento, California, 95815

United States

Collaborators and Investigators

Sponsor: Integrative Skin Science and Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-20

Study Completion Date2024-03-31

Study Record Updates

Study Start Date2023-04-20

Study Completion Date2024-03-31

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis