A Phase 2 interventional study of Cerdulatinib 0.37% gel and Vehicle gel in Vitiligo, sponsored by Dermavant Sciences GmbH. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by Dermavant Sciences GmbH · Phase 2, Interventional, and Treatment
This is a phase 2a, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel, 0.37% in adults with vitiligo
Exclusion Criteria:
Cerdulatinib 0.37% gel applied topically twice daily
Drug: Cerdulatinib 0.37% gel
Vehicle gel applied topically twice daily
Drug: Vehicle gel
Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks
Also known as: DMVT-502
Vehicle gel applied topically twice daily for 6 weeks
Vital signs
Body temperature, blood pressure, pulse (heart rate), and breathing rate (respiratory rate)
Time frame: Baseline through Week 7
Laboratory Values
Clinically significant abnormal lab values
Time frame: Baseline through Week 7
Adverse Events
Frequency, severity, and duration of adverse events
Time frame: Baseline through Week 7
Local Tolerability Scale Score
Assessment of local site investigational product administration
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 7
Concentration of cerdulatinib
Plasma concentration
Time frame: Days 1, 15, 29 and 43
Blister fluid biomarker concentration
From active treated lesions and untreated nonlesional skin
Time frame: Baseline and Week 6
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Dermavant Sciences GmbH