Recruiting

Coconut & Sunflower Seed Oil

Sponsor:

Integrative Skin Science and Research

Code:

NCT05688735

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Accepted

Interventions

Isosorbide Diester Moisturizer

Control Moisturizer

Study Details

Brief 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.

Conditions

Atopic Dermatitis

Study ID

NCT05688735

Start date

Apr 20, 2023

Status verified date

Apr, 2023

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Accepted

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 Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Experimental Topical Product

Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids

placebo comparator: Control Topical Product

Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids

Interventions

Isosorbide Diester Moisturizer

Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment

Control Moisturizer

Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment

Primary outcome measure

  • Eczema Area and Severity Index (EASI) [ Time Frame: 8 Weeks ]
  • Itch [ Time Frame: 8 Weeks ]

Central Contacts and Locations

Central contacts

Raja Sivamani, MD

(916) 750-2463raja.sivamani@integrativeskinresearch.com

Locations

Integrative Skin Science and Research

Recruiting

Sacramento, California, United States, 95815

Contacts

Caitlin Dion

916-750-2463caitlin@integrativeskinresearch.com

More Information

Sponsor

Integrative Skin Science and Research

Last update posted

Apr 14, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Integrative Skin Science and Research on 2023-04-14.