Atopic Dermatitis Clinical Trial
Official title:
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.
n/a
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