Efficacy of Topical Coal Tar in Children With Atopic Dermatitis

NCT03461302 | Unknown Phase 4

• 1 other identifier: NL59682.091.16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Disease activity

  Disease-activity measured by Eczema Area and Severity Index (EASI)

  4 weeks

Secondary Outcomes (2)

• Pruritus

  4 weeks

• Health-related quality of life

  4 weeks

Study Arms (2)

Topical Coal Tar treatment

EXPERIMENTAL

Drug: Topical coal tar

Topical Corticosteroids treatment

ACTIVE COMPARATOR

Drug: Topical corticosteroids

Interventions

Topical coal tar DRUG

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

Topical Coal Tar treatment

Topical corticosteroids DRUG

Clobetasone butyrate 0.05% ointment

Topical Corticosteroids treatment

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Dermatology

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Coal Tar; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Tessa Kouwenhoven, MD

CONTACT

+31(0)243610265; Tessa.Kouwenhoven@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: February 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 12, 2018

Record last verified: 2018-02

Locations

NL (1)