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Phosphodiesterase 4 (PDE4) inhibitor

Apremilast for Lichen Planus

Phase 2
Waitlist Available
Led By David M Pariser, MD
Research Sponsored by Virginia Clinical Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks total (12 weeks treatment, 4 weeks observation)
Awards & highlights

Study Summary

This study is designed to demonstrate to efficacy and safety of Apremilast 20mg oral administration twice daily over 12 weeks in subjects with moderate to severe lichen planus. The hypothesis is that the subjects will achieve a significant clinical improvement in their skin disease according to a specialized physician grading scale.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks total (12 weeks treatment, 4 weeks observation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks total (12 weeks treatment, 4 weeks observation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects achieving significant clinical response in cutaneous disease defined as a 2 or more grade improvement of the physician global assessment (PGA) after 12 weeks of treatment.
Secondary outcome measures
Change in the subjects' assessment of itching on a visual analogue scale (VAS) after 12 weeks of treatment relative to baseline.
Change in the subjects' dermatology life quality index (DLQI) score after 12 weeks of treatment relative to baseline.
Change in the subjects' target area lesion count after 12 weeks of treatment relative to baseline.
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApremilastExperimental Treatment1 Intervention
Apremilast 20 mg PO administered BID over 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
FDA approved

Find a Location

Who is running the clinical trial?

Virginia Clinical Research, Inc.Lead Sponsor
3 Previous Clinical Trials
139 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,226 Total Patients Enrolled
1 Trials studying Lichen Planus
42 Patients Enrolled for Lichen Planus
Clare E Foss, MDStudy ChairEastern Virginia Medical School

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus
2010. "Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01041625.
All > Otezla > Lichen Planus
~1 spots leftby Apr 2025
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