MorpheaPhase 2NCT03351114
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
A Phase 2 study testing Crisaborole in people with Morphea, run by Duke University at 1 site in United States.
Trial summary
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morphea
- What is being tested?
- Crisaborole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 10 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- Clinical diagnosis of morphea.
- <20% Total body surface area involvement.
- Does not require systemic immunosuppressive therapy for morphea.
- No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
- No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
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- No allergy to crisaborole or vehicle.
- No known renal disease
- Able to give informed consent.
- Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
- Clinical diagnosis of depression or history of suicidal ideation.
- Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
Read the detailed description
A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20.
Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits.
- Conditions
- Morphea
- Being tested
- Crisaborole
- Keywords
- Morphea, Localized Scleroderma
- Medical subject headings
- Scleroderma, Localized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrisaboroleDrug
Also called Eucrisa
Apply Crisaborole 2% ointment to affected skin twice per day.
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole 2% ointment | Experimental | Crisaborole 2% ointment applied to affected skin twice per day. Receives: Drug: Crisaborole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque
Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque.
Measured: Baseline, 12 weeks
Secondary outcomes (4)
Percentage of Reduction in DIET Score of Sentinel Plaque
The DIET (Dyspigmentation, Induration, Erythema, and Telangiectasias) score is a physician-assessed, previously validated score. Range is 0-12, and a higher score denotes increased activity or severity.
Measured: Baseline and 12 weeks
Percentage of Reduction in LoSCAT Score
LoSCAT (Localized Scleroderma Cutaneous Assessment Tool ) score is a physician-assessed, previously validated score. It has 2 components, the LoSSI (localized scleroderma skin severity index, range 0-162), which measures disease activity, and LoSDI (localized scleroderma damage index, range 0-216). The higher the number, the higher the disease activity and damage, respectively.
Measured: Baseline,12 weeks
Percentage of Reduction in Skindex-29 Score
Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life.
Measured: Baseline and 12 weeks
Change in Dermal Thickness of Sentinel Plaque by Ultrasonography
B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque
Measured: Baseline, 4, 8 and 12 weeks, optional at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start1 Sep 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MorpheaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Adela Cardones, MD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351114
- Sponsor's protocol ID
- Pro00086947
- Status last verified
- Mar 2021
- First submitted
- 20 Nov 2017
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
- ClinicalTrials.gov ID
- NCT03351114
- Acronym / sponsor ID
- Pro00086947
- Conditions
- Morphea
- Keywords
- Morphea, Localized Scleroderma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 1 Apr 2021
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 pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
Detailed description
A Phase 2, pilot, proof-of-concept, open label, single arm prospective study to assess the safety, tolerability and efficacy of using crisaborole 2% ointment for adult morphea. Patients identified by their physician, nurse, or other member of their clinical care team as meeting criteria for the study will be asked to apply crisaborole 2% ointment, twice daily, on affected plaques for 12 weeks. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque. Dermal thickness will be measured and compared before and at the end of treatment. Patients will have a clinical assessment at baseline and at weeks 4, 8 and 12. After week 12, patients who need further treatment will undergo standard of care treatment as determined by their primary dermatologist. Physician and patient reported assessment and skin imaging will be performed at baseline, week 4, 8 and 12, and at week 20. Photography will also be performed at baseline and week 12. An optional post treatment follow-up will be performed at week 20.
Medication will be provided free of charge by Pfizer, as part of the grant that is funding this study. These will be dispensed by the study group at baseline and during the subsequent clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crisaborole 2% ointment | Experimental | Drug: CrisaboroleCrisaborole 2% ointment applied to affected skin twice per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- >= 18 years of age
- Clinical diagnosis of morphea.
- <20% Total body surface area involvement.
- Does not require systemic immunosuppressive therapy for morphea.
- No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CrisaboroleAlso: EucrisaApply Crisaborole 2% ointment to affected skin twice per day. | Drug | Crisaborole 2% ointment |
Primary outcome
Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque
Time frame: Baseline, 12 weeks
Change in dermal thickness on skin biopsy. A sentinel plaque will be selected at baseline. A 4 mm skin punch biopsy will be performed at baseline and at 12 weeks, on the same affected plaque.
4 secondary outcomes
Percentage of Reduction in DIET Score of Sentinel Plaque
Time frame: Baseline and 12 weeks
Percentage of Reduction in LoSCAT Score
Time frame: Baseline,12 weeks
Percentage of Reduction in Skindex-29 Score
Time frame: Baseline and 12 weeks
Change in Dermal Thickness of Sentinel Plaque by Ultrasonography
Time frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Morphea
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingObservational study
Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
Scleroderma, Localized, Morphea
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.
Adela Cardones, MD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Crisaborole in people with Morphea, run by Duke University at 1 site in United States.
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 12 inclusion and 0 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: finished, as of the sponsor's last update on 1 Apr 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque (time frame: Baseline, 12 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 1 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.