MedPath

Apremilast for Erythema Multiforme

Phase 2
Recruiting
Conditions
Erythema Multiforme
Registration Number
NCT05875714
Lead Sponsor
Robert Micheletti
Brief Summary

This study is recruiting patients with chronic, treatment resistant erythema multiforme (EM), which is a disease that can affect the skin and mucous membranes (mucocutaneous). EM often impacts quality of life with pain, anorexia, hospitalization, and related long-term issues. While there are medications used to treat EM, no single therapeutic agent has been consistently effective for long-term management of disease. Apremilast (trade name: Otezla) is approved to treat Bechet's Disease, a different but similar mucocutaneous disease. In this study, eligible patients will receive apremilast for 6 months of treatment so we can evaluate if there is a difference in pain and the number of EM flares compared to prior to treatment with apremilast.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
8
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
EM flares on medication24 weeks

Change in frequency and duration of EM flares at 24-week evaluation.

Secondary Outcome Measures
NameTimeMethod
Pain on medication24 weeks

Change in pain severity (on 0 to 10 scale) of EM flares at 24-week evaluation

Pain off medication36 weeks

Change in pain severity (on 0-10 visual analogue scale) of EM flares at 36-week follow-up.

Flares off medication36 weeks

Change in frequency and duration of flares at 36-week follow-up.

Prednisone36 weeks

Use of prednisone as rescue therapy to treat flares.

Trial Locations

Locations (1)

Perelman Center For Advanced Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

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