A randomized controlled trial evaluating the additional effect of topical coal tar to a topical corticosteroid regimen in patients aged >16 years of age with moderate-severe atopic dermatitis

Phase 4

Withdrawn

• Conditions: 10014982; Atopic dermatitis; atopic eczema

• Registration Number: NL-OMON43163
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

- Male or female patients aged >16 years of age
- Diagnosis of AD based on the criteria of Hanifin and Rajka
- Moderate to severe AD based on EASI score >7.1

Exclusion Criteria

- Hypersensitivity and/or intolerance to topical corticosteroids or topical coal tar
- Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than potent topical corticosteroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the percentage change in EASI score at week 2.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: percentage change in EASI score at week 4, EASI-75 at week<br /><br>2 and week 4, Pruritus NRS, Patient Oriented Eczema Measure (POEM), Patient<br /><br>Global Assessment of Disease Severity (PGA), Health-related Quality of Life<br /><br>(DLQI), number of (treatment-related) adverse events, FLG mutation status, NMF<br /><br>amount in stratum corneum and skin microbiota composition.</p><br>