Clinical trial NCT05413395: Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Official title: Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eczema
Lead sponsor: GlycosBio, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Center for Clinical Studies, Texas
First posted: 2022-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized, blinded, controlled trial
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Atopic Dermatitis Severity Index (ADSI) score
timeFrame: 14 days
measure: Change in absolute abundance of S. aureus on target lesion site
timeFrame: 14 days
Secondary outcomes:
measure: Change in relative abundance of S. aureus on non-lesion site
timeFrame: 14 days
measure: Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
timeFrame: 14 days
measure: Change in Shannon Diversity Index between the target lesion site and non-lesion site
timeFrame: 14 days
measure: Change in Eczema Area and Severity Index (EASI) score
timeFrame: 14 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
Study officials:
References: