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

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413395
• Other study ID #: GLYCOS-002-AD22
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2022
• Source: GlycosBio, Inc.
• Contact: Daniel J Monticello, Ph.D.
• Phone: (346) 772-0354
• Email: dmonticello[@]glycosbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eczema

Intervention

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

Locations

Country	Name	City	State
United States	Center for Clinical Studies	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
GlycosBio, Inc.	Center for Clinical Studies, Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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