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Completed

NCT Number: NCT04831892

The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

About this study

The topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. The goal of this study is to assess the use of a natural ingredient, isosorbide diesters (IDEAS), for eczema and if it can reduce the need for the use of topical steroids.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal

Other

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

Moisturizer containing Colloidal Oatmeal only

Other

Vehicle lotion containing 0.1% colloidal oatmeal.

Primary outcomes

  1. EASI75

    Time frame: Week 4

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

  2. Change in IVAS

    Time frame: 4 weeks

    Itch severity is assessed using the Itch Visual Analog Scale.

Secondary outcomes

  1. Change in EASI score

    Time frame: Week 1

    Eczema severity is assessed using the Eczema Area and Severity Index.

  2. Change in EASI score

    Time frame: Week 5

    Eczema severity is assessed using the Eczema Area and Severity Index.

  3. Change in IVAS

    Time frame: Week 1

    Itch severity is assessed using the Itch Visual Analog Scale.

  4. Change in IVAS

    Time frame: Week 5

    Itch severity is assessed using the Itch Visual Analog Scale.

  5. Change in TEWL

    Time frame: Week 1

    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  6. Change in TEWL

    Time frame: Week 4

    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  7. Change in TEWL

    Time frame: Week 5

    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  8. Change in skin hydration level

    Time frame: Week 1

    Skin hydration levels are measured using a moisture meter.

  9. Change in skin hydration level

    Time frame: Week 4

    Skin hydration levels are measured using a moisture meter.

  10. Change in skin hydration level

    Time frame: Week 5

    Skin hydration levels are measured using a moisture meter.

  11. Change in DLQI survey responses

    Time frame: Week 1

    Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.

  12. Change in DLQI survey responses

    Time frame: Week 4

    Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.

  13. Change in DLQI survey responses

    Time frame: Week 5

    Self-reported quality of life through the Dermatology Life Quality Index, a survey completed by subjects.

  14. Change in relative abundance of S. aureus

    Time frame: 4 weeks

    Skin microbiome related measurement of S. aureus relative abundance

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Sytheon Ltd.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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