A Phase 2 interventional study of Crisaborole in Morphea, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
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.
27 studies on the registry are indexed under Scleroderma, Localized; 4 are open to participants now.
This study's enrollment of 8 is below the median of 24 across 17 interventional studies indexed under Scleroderma, Localized.
Browse Scleroderma, Localized studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Crisaborole 2% ointment applied to affected skin twice per day.
Drug: Crisaborole
Apply Crisaborole 2% ointment to affected skin twice per day.
Also known as: Eucrisa
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.
Time frame: Baseline, 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks
| Milestone | Crisaborole 2% Ointment |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | Crisaborole 2% Ointment |
|---|---|
| Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque | 5 |
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.
| percentage of reduction | Crisaborole 2% Ointment |
|---|---|
| Percentage of Reduction in DIET Score of Sentinel Plaque | 33 ± 26 |
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.
| percentage of reduction | Crisaborole 2% Ointment |
|---|---|
| LoSSI (Activity) | 37.5 ± 29 |
| LoSDI (Damage) | 5 ± 36 |
Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life.
| percentage of reduction | Crisaborole 2% Ointment |
|---|---|
| Percentage of Reduction in Skindex-29 Score | 25.7 ± 16.4 |
B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque
No measurements were reported for this outcome.
Collected over 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crisaborole 2% Ointment | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Crisaborole 2% Ointment |
|---|---|
| Median | 51 (31 to 78) |
| Sex: Female, Male(Participants) | Crisaborole 2% Ointment |
|---|---|
| Female | 7 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Crisaborole 2% Ointment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Crisaborole 2% Ointment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Crisaborole 2% Ointment |
|---|---|
| United States | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Mar 2020, 18 months.
Results were first posted in Apr 2021, 1 year after primary completion.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crisaborole