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

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)

Study Overview

• Status: Recruiting
• Conditions: Eczema
• Intervention / Treatment: Other: topical colloidal oatmeal formulation with a modified plant oil; Other: topical colloidal oatmeal formulation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel J Monticello, Ph.D.; Phone Number: (346) 772-0354; Email: dmonticello@glycosbio.com

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • Center for Clinical Studies
      • Contact: Stephen K Tyring, MD, PhD; Phone Number: 713-528-8818

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Protocol; 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; 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.
ACTIVE_COMPARATOR: Control; 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; Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Change in absolute abundance of S. aureus and S. epidermidis on the target lesion site compared to the initial absolute abundance of S. aureus and S. epidermidis at the non-lesion site (Baseline measurement) between the protocol and control arms.	14 days
Change in Shannon Diversity Index between the target lesion site and non-lesion site	Change in Shannon Diversity Index between the target lesion site compared to the initial Shannon Diversity Index at the non-lesion site (Baseline measurement).	14 days
Change in Eczema Area and Severity Index (EASI) score	Change in mean Eczema Area and Severity Index (EASI) score from baseline between the protocol and control arms. An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). For more information, see Hanifin JM, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8.	14 days

Collaborators and Investigators

• Sponsor: GlycosBio, Inc.
• Collaborators: Center for Clinical Studies, Texas

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (ACTUAL): June 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: GLYCOS-002-AD22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No