Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)

GlycosBio

Status: Enrolling

Conditions: Eczema

Treatments: Other: topical colloidal oatmeal formulation with a modified plant oil; Other: topical colloidal oatmeal formulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05413395

GLYCOS-002-AD22

Details and patient eligibility

About

This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
• Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
• Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
• Generally good health based on reported history.
• Able to discontinue all medical and over the counter topical emollients, moisturizers, and / or other skin barrier lotions.
• Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug.
• Ability to administer topical medication and be willing to adhere to the study interventions.
• Agreement to adhere to Lifestyle Considerations throughout the duration of the study.

Exclusion criteria

• Pregnancy or lactation.
• Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
• Known allergy to hydrocortisone or topical antibiotic.
• Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
• Bleach bathing in the 7 days prior to Baseline clinical visit.
• Current use of Class I-III topical corticosteroids or systemic medications (e.g. Dupixent) potentially affecting eczema or the skin.
• Surgeries or invasive medical procedures planned during course of study.
• Suspected non-compliance or non-cooperation.
• Intake of experimental drugs or experimental topical skin treatments within 30 days prior to study start.
• Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
• Diagnosis of human immunodeficiency virus in medical history.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Protocol

Experimental group

Description:

Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO) applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied.

Treatment:

Other: topical colloidal oatmeal formulation with a modified plant oil

Control

Active Comparator group

Description:

Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation amended with deionized water to match the colloidal oatmeal concentration of the Protocol arm applied to designated "target lesion sites" and "non-lesion sites" (study sites) twice per day for 14 days, followed by a 7-day regression durability period during when no product is applied.

Treatment:

Other: topical colloidal oatmeal formulation