Status:
UNKNOWN
Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
Lead Sponsor:
GlycosBio, Inc.
Collaborating Sponsors:
Center for Clinical Studies, Texas
Conditions:
Eczema
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05413395
Start Date
June 17 2022
End Date
March 1 2024
Last Update
July 5 2022
Active Locations (1)
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1
Center for Clinical Studies
Houston, Texas, United States, 77004