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Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isosorbide Diester Moisturizer
Control Moisturizer
Sponsored by
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Integrative Skin Science and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental Topical Product

Control Topical Product

Arm Description

Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids

Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)
Percent Achieving EASI 75
Itch
Change in the Itch Visual Analog Scale from Baseline

Secondary Outcome Measures

Eczema Area and Severity Index (EASI)
Change in the EASI score
Eczema Area and Severity Index (EASI)
Change in the EASI score
Eczema Area and Severity Index (EASI)
Change in the EASI score
Itch
Change in the Itch Visual Analog Scale
Itch
Change in the Itch Visual Analog Scale
Topical steroid use
Cumulative use of topical steroid use
Topical steroid use
Cumulative use of topical steroid use
Topical steroid use
Cumulative use of topical steroid use
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Skin Transepidermal Water Loss (TEWL)
TEWL measured with a Vapometer
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Skin Hydration
Level of skin hydration measured SkinMoistureMeterSC
Shift in the Skin Microbiome
Change in the relative abundance of Staphylococcus aureus on the skin

Full Information

First Posted
January 9, 2023
Last Updated
April 12, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
Sytheon Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05688735
Brief Title
Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Official Title
Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Sytheon Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind, randomized
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Topical Product
Arm Type
Active Comparator
Arm Description
Topical moisturizer With Colloidal Oatmeal and Isosorbide Diesters + Topical Steroids
Arm Title
Control Topical Product
Arm Type
Placebo Comparator
Arm Description
Topical moisturizer With Colloidal Oatmeal WITHOUT Isosorbide Diesters + Topical Steroids
Intervention Type
Other
Intervention Name(s)
Isosorbide Diester Moisturizer
Intervention Description
Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment
Intervention Type
Other
Intervention Name(s)
Control Moisturizer
Intervention Description
Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment
Primary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
Percent Achieving EASI 75
Time Frame
8 Weeks
Title
Itch
Description
Change in the Itch Visual Analog Scale from Baseline
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI)
Description
Change in the EASI score
Time Frame
1 Week
Title
Eczema Area and Severity Index (EASI)
Description
Change in the EASI score
Time Frame
4 Weeks
Title
Eczema Area and Severity Index (EASI)
Description
Change in the EASI score
Time Frame
8 Weeks
Title
Itch
Description
Change in the Itch Visual Analog Scale
Time Frame
1 Week
Title
Itch
Description
Change in the Itch Visual Analog Scale
Time Frame
4 Weeks
Title
Topical steroid use
Description
Cumulative use of topical steroid use
Time Frame
1 Week
Title
Topical steroid use
Description
Cumulative use of topical steroid use
Time Frame
4 Weeks
Title
Topical steroid use
Description
Cumulative use of topical steroid use
Time Frame
8 Weeks
Title
Skin Transepidermal Water Loss (TEWL)
Description
TEWL measured with a Vapometer
Time Frame
1 Week
Title
Skin Transepidermal Water Loss (TEWL)
Description
TEWL measured with a Vapometer
Time Frame
4 Weeks
Title
Skin Transepidermal Water Loss (TEWL)
Description
TEWL measured with a Vapometer
Time Frame
8 Weeks
Title
Skin Hydration
Description
Level of skin hydration measured SkinMoistureMeterSC
Time Frame
1 week
Title
Skin Hydration
Description
Level of skin hydration measured SkinMoistureMeterSC
Time Frame
4 weeks
Title
Skin Hydration
Description
Level of skin hydration measured SkinMoistureMeterSC
Time Frame
8 weeks
Title
Shift in the Skin Microbiome
Description
Change in the relative abundance of Staphylococcus aureus on the skin
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raja Sivamani, MD
Phone
(916) 750-2463
Email
raja.sivamani@integrativeskinresearch.com
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Dion
Phone
916-750-2463
Email
caitlin@integrativeskinresearch.com

12. IPD Sharing Statement

Learn more about this trial

Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

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