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Clinical Trials/EUCTR2016-004542-28-NL
EUCTR2016-004542-28-NL
Active, not recruiting
Phase 1

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.

Radboud University Medical Center0 sites80 target enrollmentJanuary 25, 2017
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ConditionsAtopic dermatitisMedDRA version: 19.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsEumovate Ointment (clobetasone butyrate 0.05%)Hydrocortisone acetate 1% ointmentPix lihantracis 3% in zinc oxide pasteSolutio carbonis detergens 10% in cremor vaselini lanette

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Atopic dermatitis
Sponsor
Radboud University Medical Center
Enrollment
80
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 25, 2017
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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