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

Last updated: June 30, 2022
Sponsor: GlycosBio, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Atopic Dermatitis

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT05413395
GLYCOS-002-AD22
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for theduration of the study.
  • Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-upsymptoms at screening as determined by visual analog scale (VAS).
  • Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severityindex).
  • Having a target lesion with an ADSI score of 6-12 and an erythema and pruritussubscore 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 medicallyacceptable method of birth control throughout the study and for 30 days immediatelyafter the last dose of study drug.
  • Ability to administer topical medication and be willing to adhere to the studyinterventions.
  • Agreement to adhere to Lifestyle Considerations throughout the duration of the study.

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation.
  • Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) inthe 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 clinicalvisit.
  • 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 daysprior to study start.
  • Mental disability or any other lack of fitness, in the Investigator's opinion, topreclude subject's participation in or ability to complete the study.
  • Diagnosis of human immunodeficiency virus in medical history.

Study Design

Total Participants: 60
Study Start date:
June 17, 2022
Estimated Completion Date:
March 01, 2024

Connect with a study center

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

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