NCT05688735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

January 9, 2023

Last Update Submit

April 12, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Eczema Area and Severity Index (EASI)

    Percent Achieving EASI 75

    8 Weeks

  • Itch

    Change in the Itch Visual Analog Scale from Baseline

    8 Weeks

Secondary Outcomes (15)

  • Eczema Area and Severity Index (EASI)

    1 Week

  • Eczema Area and Severity Index (EASI)

    4 Weeks

  • Eczema Area and Severity Index (EASI)

    8 Weeks

  • Itch

    1 Week

  • Itch

    4 Weeks

  • +10 more secondary outcomes

Study Arms (2)

Experimental Topical Product

ACTIVE COMPARATOR

Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids

Other: Isosorbide Diester Moisturizer

Control Topical Product

PLACEBO COMPARATOR

Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids

Other: Control Moisturizer

Interventions

Isosorbide Diester MoisturizerOTHER

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

Experimental Topical Product
Control MoisturizerOTHER

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

Control Topical Product

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Raja Sivamani, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double-blind, randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

April 20, 2023

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

US(1)