Efficacy of Topical Coal Tar in Children With Atopic Dermatitis

March 5, 2018 updated by: Radboud University Medical Center

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

Rationale/hypothesis: Atopic dermatitis (AD) is an inflammatory skin disease, occurring most frequently in children. Currently, topically applied corticosteroids are used as a standard anti-inflammatory treatment. When a corticosteroid with a high potency is used for a long period of time, adverse effects like skin atrophy and systemic effects may occur, especially in children. In addition, corticophobia among patients is an issue that warrants alternatives for the treatment of AD in children. An alternative treatment is the topical application of coal tar, which is known to be an effective and safe treatment for AD for ages, and is used in our department for decennia. Although there is convincing evidence in the literature on the safety of coal tar, evidence in the literature on the efficacy of coal tar in the treatment of AD is lacking, especially in children.

Objective: To evaluate efficacy of topical treatment with coal tar compared to topical treatment with corticosteroids in children aged 1 to <16 years with moderate to severe AD

Study design: investigator-initiated, parallel-group randomized controlled pilot study

Study population: Children aged 1 to <16 years with moderate-severe AD

Intervention: Patients will be randomized in two groups: (1) topical treatment with coal tar or (2) topical treatment with moderate potency corticosteroids for a treatment duration of 4 weeks.

Main study parameters/endpoints: The primary outcome is the percentage change in EASI score at week 2.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Nijmegen, Netherlands
        • Recruiting
        • Department of Dermatology
        • Contact:
          • Tessa Kouwenhoven, MD
          • Phone Number: +31(0)243610265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of AD based on the criteria of Hanifin and Rajka
  • Moderate to severe AD based on EASI score >7.1
  • Willing and able to comply with visits and study-related procedures
  • Provide signed informed consent (if patient >12 years of age) and/or signed informed consent provided by the parents or legal guardian (all participating patients)
  • Able to understand and complete study-related questionnaires, or parent or legal guardian is able to understand and complete study-related questionnaires
  • Willing to avoid excessive sunlight

Exclusion Criteria:

  • Hypersensitivity and/or intolerance to topical corticosteroids or topical coal tar
  • Treatment with any of the following before baseline:

    • Topical treatment with corticosteroids within 24 hours before baseline
    • Topical treatment with coal tar, tacrolimus and/or pimecrolimus within 2 weeks before baseline
    • Topical treatment with antibiotics or antifungal treatment within 7 days before baseline
    • Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy for AD within 8 weeks before baseline
    • Investigational drugs within 8 weeks or 5 half-lives (whichever is longer)
    • Use of systemic antibiotic therapy, systemic antifungal therapy and/or biologicals within 6 months before baseline
  • Planned or anticipated use of any prohibited medication during the treatment and follow-up period:

    • Other medication than the prescribed study medication used for the treatment of AD, including topical calcineurin inhibitors, prescription moisturizers containing additives such as urea, antihistamines, phototherapy, systemic treatment with an immunosuppressive/immunomodulatory agent such as cyclosporine, methotrexate or biologics
    • Systemic antibiotic and/or antifungal therapy
  • Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than moderate potency topical corticosteroids
  • Pregnancy or breast feeding, or planning to become pregnant or breast feed
  • Presence of skin co-morbidities that may interfere with study assessments
  • Presence of concomitant illness that would, in the investigator's judgment, adversely affect the patient's participation in the study
  • Presence of chronic hepatic or renal insufficiency
  • Presence of immunodeficiency syndromes including HIV
  • Presence of HBV or HCV
  • Any other medical or psychological condition that would represent an unreasonable risk to the patient, make the patient's participation unreliable or interfere with study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Coal Tar treatment
Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
Active Comparator: Topical Corticosteroids treatment
Clobetasone butyrate 0.05% ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 4 weeks
Disease-activity measured by Eczema Area and Severity Index (EASI)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pruritus
Time Frame: 4 weeks
VAS pruritus
4 weeks
Health-related quality of life
Time Frame: 4 weeks
DLQI
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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