NCT04831892

Brief Summary

The overall objective of this study is to assess how a natural ingredient, isosorbide diesters (IDEAS), works in association with colloidal oatmeal for eczema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

April 1, 2021

Last Update Submit

November 5, 2022

Conditions

Atopic Dermatitis

Keywords

eczemaskindermatologyisosorbide diestersskin microbiome

Outcome Measures

Primary Outcomes (2)

  • EASI75

    75% improvement in Eczema severity is assessed using the Eczema Area and Severity Index

    Week 4

  • Change in IVAS

    Itch severity is assessed using the Itch Visual Analog Scale.

    4 weeks

Secondary Outcomes (14)

  • Change in EASI score

    Week 1

  • Change in EASI score

    Week 5

  • Change in IVAS

    Week 1

  • Change in IVAS

    Week 5

  • Change in TEWL

    Week 1

  • +9 more secondary outcomes

Study Arms (2)

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

EXPERIMENTAL

Topical lotion containing isosorbide diesters and colloidal oatmeal to be applied to the entire body once daily.

Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Moisturizer containing colloidal oatmeal

ACTIVE COMPARATOR

Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily

Other: Moisturizer containing Colloidal Oatmeal only

Interventions

Moisturizer Containing Isosorbide Diesters and Colloidal OatmealOTHER

Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
Moisturizer containing Colloidal Oatmeal onlyOTHER

Vehicle lotion containing 0.1% colloidal oatmeal.

Moisturizer containing colloidal oatmeal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18 or over
  • Subjects with a diagnosis of mild to moderate eczema with a SCORAD between 1-50.

You may not qualify if:

  • Individuals who have a known allergy to isosorbide diesters.
  • 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

Location

Related Publications (1)

  • Nadora D, Burney W, Chaudhuri RK, Galati A, Min M, Fong S, Lo K, Chambers CJ, Sivamani RK. Prospective Randomized Double-Blind Vehicle-Controlled Study of Topical Coconut and Sunflower Seed Oil-Derived Isosorbide Diesters on Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(S1):S62-S69. doi: 10.1089/derm.2023.0329.

    PMID: 38394048DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

April 12, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

US(1)