A Pilot Study of Efficacy and Safety of SIM05 in Adults With Atopic Eczema

Not Applicable

Active, not recruiting

• Conditions: Atopic Eczema

• Registration Number: NCT06230991
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - Adults age 18 or older physician-diagnosed atopic eczema;<br><br> - Agree to sign the informed consent form<br><br>Exclusion Criteria:<br><br> - Adults with other documented chronic and clinically significant dermatologic<br> diseases that may interfere with the evaluation of cutaneous signs and symptoms.<br> Common conditions such as acne are permissible.<br><br> - Adults with atopic eczema who have taken antibiotics within one months prior to<br> recruitment.<br><br> - Adults with atopic eczema who require systemic immunosuppressive treatments (e.g.<br> azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, biologics) within<br> three months prior to recruitment, or who are taking systemic steroids within one<br> month.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Eczema Area and Severity Index (EASI) across 16 weeks.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving 50% and 75% reduction in EASI (EASI-50, EASI-75).;Change in pruritus numerical rating scales (pruritus-NRS) across 16 weeks.;Changes in faecal microbial profiling across 16 weeks.;Adverse events reported during the study period.;Change in Dermatology life quality index (DLQI) across 16 weeks.