Efficacy of Topical Coal Tar in Children With Atopic Dermatitis

NCT ID: NCT03461302

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-09-01

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical Coal Tar treatment

Group Type: EXPERIMENTAL

Topical coal tar

Intervention Type: DRUG

Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste

Topical Corticosteroids treatment

Group Type: ACTIVE_COMPARATOR

Topical corticosteroids

Intervention Type: DRUG

Clobetasone butyrate 0.05% ointment

Interventions

Topical coal tar

Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste

Intervention Type: DRUG

Topical corticosteroids

Clobetasone butyrate 0.05% ointment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Dermatology

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Tessa Kouwenhoven, MD

Role: CONTACT

Tessa.Kouwenhoven@radboudumc.nl

+31(0)243610265

Facility Contacts

Tessa Kouwenhoven, MD

Role: primary

+31(0)243610265

Other Identifiers

NL59682.091.16

Identifier Type: -

Identifier Source: org_study_id