Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03461302|
Recruitment Status : Unknown
Verified February 2018 by Radboud University.
Recruitment status was: Recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Topical coal tar Drug: Topical corticosteroids||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
|Experimental: Topical Coal Tar treatment||
Drug: Topical coal tar
Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
|Active Comparator: Topical Corticosteroids treatment||
Drug: Topical corticosteroids
Clobetasone butyrate 0.05% ointment
- Disease activity [ Time Frame: 4 weeks ]Disease-activity measured by Eczema Area and Severity Index (EASI)
- Pruritus [ Time Frame: 4 weeks ]VAS pruritus
- Health-related quality of life [ Time Frame: 4 weeks ]DLQI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461302
|Contact: Tessa Kouwenhoven, MD||+31(0)243610265||Tessa.Kouwenhoven@radboudumc.nl|
|Department of Dermatology||Recruiting|
|Contact: Tessa Kouwenhoven, MD +31(0)243610265|