Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
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|ClinicalTrials.gov Identifier: NCT03351114|
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : September 12, 2018
|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)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
- Change in dermal thickness of sentinel plaque [ Time Frame: Baseline, 12 weeks, optional at 20 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.
- Change in DIET score of sentinel plaque [ Time Frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks ]The DIET (Dyspigmentation, Induration, Erythema, and Telangiectasias) score is a physician-assessed, previously validated score.
- Change in LoSCAT score [ Time Frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks ]LoSCAT (Localized Scleroderma Cutaneous Assessment Tool ) score is a physician-assessed, previously validated score.
- Change in Skindex-29 score [ Time Frame: Baseline, 4, 8 and 12 weeks, optional at 20 weeks ]Skindex-29 is a health-related quality of life score
- 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
|Contact: Kim Scoggins, RN||(919) firstname.lastname@example.org|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Contact: Kim Scoggins, RN|
|Principal Investigator:||Adela Cardones, MD||Duke UMC|