Efficacy of topical coal tar in children with atopic dermatitis

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 19.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004542-28-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified