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The Effect of Isosorbide Diesters Based Moisturizer on Skin Health

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ClinicalTrials.gov Identifier: NCT04831892
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Sytheon Ltd.
Information provided by (Responsible Party):
Raja Sivamani, Integrative Skin Science and Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal Other: Moisturizer containing Colloidal Oatmeal only Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Isosorbide Diesters Based Moisturizer on Skin Health
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal
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
Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
Active Comparator: Moisturizer containing colloidal oatmeal
Topical moisturizer with colloidal oatmeal to be applied to the entire body once daily
 Other: Moisturizer containing Colloidal Oatmeal only
Vehicle lotion containing 0.1% colloidal oatmeal.


Outcome Measures
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Primary Outcome Measures :
  1. Change in SCORAD [ Time Frame: 4 weeks ]
    Eczema severity is assessed using the SCORing Atopic Dermatitis validated scale.

  2. Change in EASI score [ Time Frame: Week 4 ]
    Eczema severity is assessed using the Eczema Area and Severity Index.


Secondary Outcome Measures :
  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 SCORAD [ Time Frame: Week 1 ]
    Eczema severity is assessed using the SCORing Atopic Dermatitis validated scale.

  4. Change in SCORAD [ Time Frame: Week 5 ]
    Eczema severity is assessed using the SCORing Atopic Dermatitis validated scale.

  5. Change in IVAS [ Time Frame: Week 1 ]
    Itch severity is assessed using the Itch Visual Analog Scale.

  6. Change in IVAS [ Time Frame: Week 4 ]
    Itch severity is assessed using the Itch Visual Analog Scale.

  7. Change in IVAS [ Time Frame: Week 5 ]
    Itch severity is assessed using the Itch Visual Analog Scale.

  8. Change in TEWL [ Time Frame: Week 1 ]
    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  9. Change in TEWL [ Time Frame: Week 4 ]
    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  10. Change in TEWL [ Time Frame: Week 5 ]
    Transepidermal water loss (TEWL) is measured with a skin vapometer.

  11. Change in skin hydration level [ Time Frame: Week 1 ]
    Skin hydration levels are measured using a moisture meter.

  12. Change in skin hydration level [ Time Frame: Week 4 ]
    Skin hydration levels are measured using a moisture meter.

  13. Change in skin hydration level [ Time Frame: Week 5 ]
    Skin hydration levels are measured using a moisture meter.

  14. Change in skin pH level [ Time Frame: Week 1 ]
    Skin pH levels are measured using a skin pH meter.

  15. Change in skin pH level [ Time Frame: Week 4 ]
    Skin pH levels are measured using a skin pH meter.

  16. Change in skin pH level [ Time Frame: Week 5 ]
    Skin pH levels are measured using a skin pH meter.

  17. 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.

  18. 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.

  19. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831892


Contacts
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Contact: Raja Sivamani, M.D. 916-524-1216 raja.sivamani@integrativeskinresearch.com

Locations
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United States, California
Integrative Skin Science and Research Recruiting
Sacramento, California, United States, 95815
Contact: Raja Sivamani, M.D.    916-524-1216    raja.sivamani@integrativeskinresearch.com   
Sponsors and Collaborators
Integrative Skin Science and Research
Sytheon Ltd.
More Information
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Responsible Party: Raja Sivamani, Principal Investigator, Integrative Skin Science and Research
ClinicalTrials.gov Identifier: NCT04831892    
Other Study ID Numbers: I20-ISO1
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Raja Sivamani, Integrative Skin Science and Research:
eczema
skin
dermatology
isosorbide diesters
skin microbiome
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Isosorbide
 Isosorbide Dinitrate
Isosorbide-5-mononitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action