Phase 2
N=8
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
Morphea
Bottom Line
View on ClinicalTrials.gov: NCT03351114 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Crisaborole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had a Reduction in Dermal Thickness of Sentinel Plaque |
5 | — |
| SECONDARY Percentage of Reduction in DIET Score of Sentinel Plaque |
33 | — |
| SECONDARY Percentage of Reduction in LoSCAT Score |
37.5; 5 | — |
| SECONDARY Percentage of Reduction in Skindex-29 Score |
25.7 | — |
| SECONDARY Change in Dermal Thickness of Sentinel Plaque by Ultrasonography |
— | — |
Summary
This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
Eligibility Criteria
Inclusion Criteria
- >= 18 years of age
- Clinical diagnosis of morphea.
- =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.
- 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 Women with a positive urine hCG at any time during the study will be withdrawn from the study.
Data sourced from ClinicalTrials.gov (NCT03351114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.