Last updated: June 30, 2022
Sponsor: GlycosBio, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Allergy
Atopic Dermatitis
Dermatitis, Atopic
Treatment
N/AClinical Study ID
NCT05413395
GLYCOS-002-AD22
Ages > 18 All Genders
Study Summary
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 StatesActive - Recruiting

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