Back to resultsEfficacy of Topical Coal Tar in Children With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Topical coal tar
Topical corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
- Systemic antibiotic and/or antifungal therapy
- Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than moderate potency topical corticosteroids
- Pregnancy or breast feeding, or planning to become pregnant or breast feed
- Presence of skin co-morbidities that may interfere with study assessments
- Presence of concomitant illness that would, in the investigator's judgment, adversely affect the patient's participation in the study
- Presence of chronic hepatic or renal insufficiency
- Presence of immunodeficiency syndromes including HIV
- Presence of HBV or HCV
- Any other medical or psychological condition that would represent an unreasonable risk to the patient, make the patient's participation unreliable or interfere with study assessments
Sites / Locations
- Department of DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topical Coal Tar treatment
Topical Corticosteroids treatment
Arm Description
Outcomes
Primary Outcome Measures
Disease activity
Disease-activity measured by Eczema Area and Severity Index (EASI)
Secondary Outcome Measures
Pruritus
VAS pruritus
Health-related quality of life
DLQI
Full Information
NCT ID
NCT03461302
First Posted
March 5, 2018
Last Updated
March 5, 2018
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03461302
Brief Title
Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical Coal Tar treatment
Arm Type
Experimental
Arm Title
Topical Corticosteroids treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Topical coal tar
Intervention Description
Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
Intervention Type
Drug
Intervention Name(s)
Topical corticosteroids
Intervention Description
Clobetasone butyrate 0.05% ointment
Primary Outcome Measure Information:
Title
Disease activity
Description
Disease-activity measured by Eczema Area and Severity Index (EASI)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pruritus
Description
VAS pruritus
Time Frame
4 weeks
Title
Health-related quality of life
Description
DLQI
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Systemic antibiotic and/or antifungal therapy
Indication for systemic therapy or a medical need to use a higher level of topical corticosteroids than moderate potency topical corticosteroids
Pregnancy or breast feeding, or planning to become pregnant or breast feed
Presence of skin co-morbidities that may interfere with study assessments
Presence of concomitant illness that would, in the investigator's judgment, adversely affect the patient's participation in the study
Presence of chronic hepatic or renal insufficiency
Presence of immunodeficiency syndromes including HIV
Presence of HBV or HCV
Any other medical or psychological condition that would represent an unreasonable risk to the patient, make the patient's participation unreliable or interfere with study assessments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa Kouwenhoven, MD
Phone
+31(0)243610265
Email
Tessa.Kouwenhoven@radboudumc.nl
Facility Information:
Facility Name
Department of Dermatology
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessa Kouwenhoven, MD
Phone
+31(0)243610265
12. IPD Sharing Statement
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Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
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