NCT03461302

Efficacy of Topical Coal Tar in Children With Atopic Dermatitis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Topical coal tar	Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
DRUG	Topical corticosteroids	Clobetasone butyrate 0.05% ointment

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-08-01
• Completion: 2019-09-01
• First posted: 2018-03-12
• Last updated: 2018-03-12

Locations

1 site across 1 country: Netherlands