A randomized controlled pilot study comparing the efficacy of topical coal tar to topical corticosteroids in children aged 1 to < 16 years with moderate-severe atopic dermatitis.

Phase 4

Completed

• Conditions: Atopic dermatitis; atopic eczema; 10014982

• Registration Number: NL-OMON42910
• 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: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- Male or female patients aged between 1 and <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 moderate potency 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 VAS, Patient Oriented Eczema Measure (POEM), Patient<br /><br>Global Assessment of Disease Severity (PGA), Health-related Quality of Life<br /><br>(CDLQI), Family impact of childhood Atopic Dermatitis (DFI), number of<br /><br>(treatment-related) adverse events, FLG mutation status, NMF amount in stratum<br /><br>corneum and skin microbiota composition.</p><br>