SclerodermaPhase 1NCT02680717
Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea
A Phase 1 study testing Clobetasol, Calcipotriene and Tacrolimus in people with Scleroderma, run by Medical College of Wisconsin.
Trial summary
This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- Clobetasol, Calcipotriene and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2017
- Phase
- Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks
Who cannot join
- children receiving phototherapy or systemic therapy for their morphea
- children with linear or generalized morphea
- lesions on the face
- greater than 3% body surface area involvement
- open or ulcerated skin within morphea lesions
About this study
Official title: Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea
This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.
Read the detailed description
Morphea, also known as localized scleroderma, is a rare autoimmune fibrosing disorder that affects children and adults. Morphea causes significant morbidity through atrophy and fibrosis of the skin and underlying structures. Treatment can halt the progression of disease but cannot reverse disease damage, leaving children with disfiguring scars and sometimes functional impairment. Consequently, it is of extreme importance to intervene early in the disease course with effective therapies to limit morbidity.
Circumscribed morphea is the second most common subtype in children, comprising approximately 1/3 of pediatric morphea cases. It is a disfiguring disease that can cause pain and pruritus. There are no FDA-approved treatments and no consensus exists on the ideal therapy for circumscribed morphea, either in adults or children. Most physicians use topical medications for circumscribed morphea yet there is little evidence to support these therapies. Topical immune modulators such as tacrolimus, imiquimod, and calcipotriene have been investigated in small studies, though these trials were limited by very small sample sizes of 9-19 patients and lack of a control in most. Surveys have demonstrated that topical steroids are the most commonly prescribed medication, even though the only evidence to support their use comes from case reports. With insufficient evidence regarding topical therapies, providers have no guidance when making treatment decisions, practice patterns vary widely even amongst pediatric dermatologists, and children continue with preventable scars.
The investigators specific aim is to identify effective topical therapy for circumscribed morphea. The investigators will utilize a comparative cohort study design to evaluate the comparative effectiveness of three topical medications: clobetasol ointment, calcipotriene ointment, and tacrolimus 0.1% ointment. The investigators will enroll subjects at CHW and other institutions to achieve the study enrollment necessary to power this study.
- Conditions
- Scleroderma
- Being tested
- Clobetasol, Calcipotriene, Tacrolimus
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClobetasolDrug
ointment, twice daily (alternating weeks)
CalcipotrieneDrug
ointment, twice daily
TacrolimusDrug
ointment, 0.1%, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Active comparator | Calcipotriene 0.005% ointment Receives: Drug: Calcipotriene |
| Treatment 2 | Active comparator | Clobetasol 0.05% ointment Receives: Drug: Clobetasol |
| Treatment 3 | Active comparator | Tacrolimus 0.1% ointment Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Measured: 2 months
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Unable to obtain IRB approval at all sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, Seattle Children's Hospital, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Yvonne Chiu, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680717
- Sponsor's protocol ID
- 730382-2
- Status last verified
- Jul 2018
- First submitted
- 9 Feb 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea
- ClinicalTrials.gov ID
- NCT02680717
- Acronym / sponsor ID
- 730382-2
- Conditions
- Scleroderma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain IRB approval at all sites
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Mayo Clinic, Seattle Children's Hospital, University of Toronto
- Study start
- Mar 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 11 Feb 2016 (estimated)
- 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.
This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.
Detailed description
Morphea, also known as localized scleroderma, is a rare autoimmune fibrosing disorder that affects children and adults. Morphea causes significant morbidity through atrophy and fibrosis of the skin and underlying structures. Treatment can halt the progression of disease but cannot reverse disease damage, leaving children with disfiguring scars and sometimes functional impairment. Consequently, it is of extreme importance to intervene early in the disease course with effective therapies to limit morbidity.
Circumscribed morphea is the second most common subtype in children, comprising approximately 1/3 of pediatric morphea cases. It is a disfiguring disease that can cause pain and pruritus. There are no FDA-approved treatments and no consensus exists on the ideal therapy for circumscribed morphea, either in adults or children. Most physicians use topical medications for circumscribed morphea yet there is little evidence to support these therapies. Topical immune modulators such as tacrolimus, imiquimod, and calcipotriene have been investigated in small studies, though these trials were limited by very small sample sizes of 9-19 patients and lack of a control in most. Surveys have demonstrated that topical steroids are the most commonly prescribed medication, even though the only evidence to support their use comes from case reports. With insufficient evidence regarding topical therapies, providers have no guidance when making treatment decisions, practice patterns vary widely even amongst pediatric dermatologists, and children continue with preventable scars.
The investigators specific aim is to identify effective topical therapy for circumscribed morphea. The investigators will utilize a comparative cohort study design to evaluate the comparative effectiveness of three topical medications: clobetasol ointment, calcipotriene ointment, and tacrolimus 0.1% ointment. The investigators will enroll subjects at CHW and other institutions to achieve the study enrollment necessary to power this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Active comparator | Drug: CalcipotrieneCalcipotriene 0.005% ointment |
| Treatment 2 | Active comparator | Drug: ClobetasolClobetasol 0.05% ointment |
| Treatment 3 | Active comparator | Drug: TacrolimusTacrolimus 0.1% ointment |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks
Key exclusion criteria (5 listed)
- children receiving phototherapy or systemic therapy for their morphea
- children with linear or generalized morphea
- lesions on the face
- greater than 3% body surface area involvement
- open or ulcerated skin within morphea lesions
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 |
|---|---|---|
| Clobetasolointment, twice daily (alternating weeks) | Drug | Treatment 2 |
| Calcipotrieneointment, twice daily | Drug | Treatment 1 |
| Tacrolimusointment, 0.1%, twice daily | Drug | Treatment 3 |
Primary outcome
Visual Analog Scale
Time frame: 2 months
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Visual Analog Scale
Time frame: 4 months
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Yvonne Chiu, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clobetasol, Calcipotriene and Tacrolimus in people with Scleroderma, run by Medical College of Wisconsin.
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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 2 months). The study lists 2 primary outcomes in all. 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 18 Jul 2018.