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

Primary Purpose

Eczema

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
topical colloidal oatmeal formulation with a modified plant oil
topical colloidal oatmeal formulation
Sponsored by
GlycosBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Clinical StudiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protocol

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
June 7, 2022
Last Updated
June 30, 2022
Sponsor
GlycosBio, Inc.
Collaborators
Center for Clinical Studies, Texas
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1. Study Identification

Unique Protocol Identification Number
NCT05413395
Brief Title
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Official Title
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycosBio, Inc.
Collaborators
Center for Clinical Studies, Texas

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, randomized, blinded, controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
topical colloidal oatmeal formulation with a modified plant oil
Intervention Description
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
Intervention Name(s)
topical colloidal oatmeal formulation
Intervention Description
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation
Primary Outcome Measure Information:
Title
Atopic Dermatitis Severity Index (ADSI) score
Description
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.
Time Frame
14 days
Title
Change in absolute abundance of S. aureus on target lesion site
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in relative abundance of S. aureus on non-lesion site
Description
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.
Time Frame
14 days
Title
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Description
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.
Time Frame
14 days
Title
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Description
Change in Shannon Diversity Index between the target lesion site compared to the initial Shannon Diversity Index at the non-lesion site (Baseline measurement).
Time Frame
14 days
Title
Change in Eczema Area and Severity Index (EASI) score
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Monticello, Ph.D.
Phone
(346) 772-0354
Email
dmonticello@glycosbio.com
Facility Information:
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen K Tyring, MD, PhD
Phone
713-528-8818

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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