Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Virginia Clinical Research, Inc.
Study ID
NCT01041625
Phase
PHASE2
Status
Unknown

Conditions

  • Lichen Planus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 1, 2010
Start date
Feb 28, 2010
Status verified
Dec 2009
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apremilast
    Apremilast 20 mg PO administered BID over 12 weeks

Primary Outcome Measure

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. [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Clinical Research Inc.NorfolkVirginia23507
Stefanie A Hirano, MD
[email protected]
757-625-0151
Clare E Foss, MD
[email protected]
757-625-0151
David M Pariser, MD (PRINCIPAL_INVESTIGATOR)
Robert J Pariser, MD (SUB_INVESTIGATOR)
Cyndi Torosky, MD (SUB_INVESTIGATOR)
Clare E Foss, MD (SUB_INVESTIGATOR)
Stefanie A Hirano, MD (SUB_INVESTIGATOR)

Find similar trials in Norfolk, VA

By research site
Virginia Clinical Research Inc.· Norfolk, VA

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