Assessment of the Effects on the Skin Microbiome of Amend... | NCT05413395

Status Module

Name	Class
Center for Clinical Studies, Texas	OTHER

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Protocol	Experimental	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.	Other: topical colloidal oatmeal formulation with a modified plant oil
Control	Active Comparator	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.	Other: topical colloidal oatmeal formulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
topical colloidal oatmeal formulation with a modified plant oil	Other	Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO). The AO contains proprietary blends of plant oils that have selective antimicrobial properties.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Atopic Dermatitis Severity Index (ADSI) score	Change in mean Atopic Dermatitis Severity Index (ADSI) score from baseline between the protocol and control arms by the 14-day application period. The ADSI comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum score of 15. The maximum score means a worsen condition.	14 days
Change in absolute abundance of S. aureus on target lesion site	Difference in reduction in absolute abundance of S. aureus on target lesion site compared to initial absolute abundance at target lesion site (Baseline measurement) between the protocol and control arms by 14-day application period of application period.	14 days

Secondary Outcomes

Measure	Description	Time Frame
Change in relative abundance of S. aureus on non-lesion site	Change in relative abundance of S. aureus on non-lesion site compared to initial relative abundance at target lesion site (Baseline measurement) between the protocol and control arms.	14 days
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.

Eligibility Module

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.

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous