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

NCT05413395 | Unknown

• 1 other identifier: GLYCOS-002-AD22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Eczema

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• Change in relative abundance of S. aureus on non-lesion site

  14 days

• Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.

  14 days

• Change in Shannon Diversity Index between the target lesion site and non-lesion site

  14 days

• Change in Eczema Area and Severity Index (EASI) score

  14 days

Study Arms (2)

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

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.

Protocol

topical colloidal oatmeal formulation OTHER

Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlycosBio, Inc.: lead
• Center for Clinical Studies, Texas: collaborator

Study Sites (1)

Center for Clinical Studies

Houston, Texas, 77004, United States

RECRUITING

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Central Study Contacts

Daniel J Monticello, Ph.D.

CONTACT

(346) 772-0354; dmonticello@glycosbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, blinded, controlled trial

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: June 17, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)