Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT03461302
Status:
UNKNOWN
Last Update Posted:
2018-03-12
First Post:
2018-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: