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

NCT ID: NCT05413395

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2024-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

topical colloidal oatmeal formulation with a modified plant oil

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

topical colloidal oatmeal formulation

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

topical colloidal oatmeal formulation

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Clinical Studies, Texas

OTHER

Sponsor Role: collaborator

GlycosBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Clinical Studies

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel J Monticello, Ph.D.

Role: CONTACT

dmonticello@glycosbio.com

(346) 772-0354

Facility Contacts

Stephen K Tyring, MD, PhD

Role: primary

713-528-8818

Other Identifiers

GLYCOS-002-AD22

Identifier Type: -

Identifier Source: org_study_id