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

Atopic Dermatitis Clinical Trial

Official title:

Prospective Randomized Vehicle-Controlled, Double-Blind Assessment of the Effect of Coconut and Sunflower Seed Oil Derived Isosorbide Diseters and Colloidial Oatmeal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688735
• Other study ID #: IDEAS_PEDS_AD
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2023
• Source: Integrative Skin Science and Research
• Contact: Raja Sivamani, MD
• Phone: (916) 750-2463
• Email: raja.sivamani[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis

Intervention

Other:
• Isosorbide Diester Moisturizer
Isosorbide Diesters (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5% ointment
• Control Moisturizer
Topical vehicle (with 0.1% colloidal oatmeal) + Topical Hydrocortisone 2.5 % ointment

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Sytheon Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eczema Area and Severity Index (EASI)	Percent Achieving EASI 75	8 Weeks
Primary	Itch	Change in the Itch Visual Analog Scale from Baseline	8 Weeks
Secondary	Eczema Area and Severity Index (EASI)	Change in the EASI score	1 Week
Secondary	Eczema Area and Severity Index (EASI)	Change in the EASI score	4 Weeks
Secondary	Eczema Area and Severity Index (EASI)	Change in the EASI score	8 Weeks
Secondary	Itch	Change in the Itch Visual Analog Scale	1 Week
Secondary	Itch	Change in the Itch Visual Analog Scale	4 Weeks
Secondary	Topical steroid use	Cumulative use of topical steroid use	1 Week
Secondary	Topical steroid use	Cumulative use of topical steroid use	4 Weeks
Secondary	Topical steroid use	Cumulative use of topical steroid use	8 Weeks
Secondary	Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	1 Week
Secondary	Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	4 Weeks
Secondary	Skin Transepidermal Water Loss (TEWL)	TEWL measured with a Vapometer	8 Weeks
Secondary	Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	1 week
Secondary	Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	4 weeks
Secondary	Skin Hydration	Level of skin hydration measured SkinMoistureMeterSC	8 weeks
Secondary	Shift in the Skin Microbiome	Change in the relative abundance of Staphylococcus aureus on the skin	8 weeks