Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
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|ClinicalTrials.gov Identifier: NCT03351114|
Recruitment Status : Completed
First Posted : November 22, 2017
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Morphea||Drug: Crisaborole||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea|
|Actual Study Start Date :||September 1, 2018|
|Actual Primary Completion Date :||March 10, 2020|
|Actual Study Completion Date :||March 10, 2020|
Experimental: Crisaborole 2% ointment
Crisaborole 2% ointment applied to affected skin twice per day.
Apply Crisaborole 2% ointment to affected skin twice per day.
Other Name: Eucrisa
- 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.
- Percentage of Reduction in DIET Score of Sentinel Plaque [ Time Frame: Baseline and 12 weeks ]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 in LoSCAT Score [ Time Frame: Baseline,12 weeks ]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 in Skindex-29 Score [ Time Frame: Baseline and 12 weeks ]Skindex-29 is a health-related quality of life score; minimum score 30, maximum 150. Lower score indicates a better quality of life.
- Change in Dermal Thickness of Sentinel Plaque by Ultrasonography [ Time Frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks ]B-Mode ultrasonographic imaging will be utilized to measure dermal thickness of the sentinel plaque
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351114
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Adela Cardones, MD||Duke UMC|