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
Overview
- Phase
- Phase 4
- Intervention
- Topical coal tar
- Conditions
- Atopic Dermatitis
- Sponsor
- Radboud University Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Disease activity
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
Topical Coal Tar treatment
Intervention: Topical coal tar
Topical Corticosteroids treatment
Intervention: Topical corticosteroids
Outcomes
Primary Outcomes
Disease activity
Time Frame: 4 weeks
Disease-activity measured by Eczema Area and Severity Index (EASI)
Secondary Outcomes
- Pruritus(4 weeks)
- Health-related quality of life(4 weeks)