Atopic DermatitisPhase 4NCT03461302
Efficacy of Topical Coal Tar in Children With Atopic Dermatitis
A Phase 4 study testing Topical coal tar and Topical corticosteroids in people with Atopic Dermatitis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Topical coal tar and Topical corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2018to 1 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Department of Dermatology
Nijmegen
Tessa Kouwenhoven, MD, +31(0)243610265
About this study
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
Read more
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
- Being tested
- Topical coal tar, Topical corticosteroids
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical coal tarDrug
Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
Topical corticosteroidsDrug
Clobetasone butyrate 0.05% ointment
| Study group | Role | What they receive |
|---|---|---|
| Topical Coal Tar treatment | Experimental | Not described Receives: Drug: Topical coal tar |
| Topical Corticosteroids treatment | Active comparator | Not described Receives: Drug: Topical corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity
Disease-activity measured by Eczema Area and Severity Index (EASI)
Measured: 4 weeks
Secondary outcomes (2)
Pruritus
VAS pruritus
Measured: 4 weeks
Health-related quality of life
DLQI
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Feb 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461302
- Sponsor's protocol ID
- NL59682.091.16
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03461302
- Acronym / sponsor ID
- NL59682.091.16
- Conditions
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Coal Tar treatment | Experimental | Drug: Topical coal tar |
| Topical Corticosteroids treatment | Active comparator | Drug: Topical corticosteroids |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- Hypersensitivity and/or intolerance to topical corticosteroids or topical coal tar
- Treatment with any of the following before baseline:
- Planned or anticipated use of any prohibited medication during the treatment and follow-up period:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical coal tarSolution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste | Drug | Topical Coal Tar treatment |
| Topical corticosteroidsClobetasone butyrate 0.05% ointment | Drug | Topical Corticosteroids treatment |
Primary outcome
Disease activity
Time frame: 4 weeks
Disease-activity measured by Eczema Area and Severity Index (EASI)
2 secondary outcomes
Pruritus
Time frame: 4 weeks
Health-related quality of life
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical coal tar and Topical corticosteroids in people with Atopic Dermatitis, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tessa Kouwenhoven, MD (+31(0)243610265, Tessa.Kouwenhoven@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.