Recruiting

Activated Oil

Sponsor:

GlycosBio, Inc.

Code:

NCT05413395

Conditions

Eczema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

topical colloidal oatmeal formulation with a modified plant oil

topical colloidal oatmeal formulation

Study Details

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 ID

NCT05413395

Start date

Jun 17, 2022

Status verified date

Jun, 2022

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

topical colloidal oatmeal formulation

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

Primary outcome measure

  • Atopic Dermatitis Severity Index (ADSI) score [ Time Frame: 14 days ]
  • Change in absolute abundance of S. aureus on target lesion site [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Daniel J Monticello, Ph.D.

(346) 772-0354dmonticello@glycosbio.com

Locations

Center for Clinical Studies

Recruiting

Houston, Texas, United States, 77004

Contacts

Stephen K Tyring, MD, PhD

713-528-8818

More Information

Sponsor

GlycosBio, Inc.

Last update posted

Jul 5, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlycosBio, Inc. on 2022-07-05.