Apremilast for Erythema Multiforme

Conditions

• Erythema Multiforme

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Apremilast — DRUG
  Apremilast (Otezla), oral medication Day 1: 10 mg in the morning. Day 2: 10 mg in the morning and 10 mg in the evening. Day 3: 10 mg in the morning and 20 mg in the evening. Day 4: 20 mg in the morning and 20 mg in the evening. Day 5: 20 mg in the morning and 30 mg in the evening Day 6: 30 mg twice daily Maintenance dosing: 30 mg twice daily

Study Details

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.

Key Dates

First listed

May 25, 2023

Start date

Jan 13, 2022

Status verified

May 2026

Primary completion

Dec 31, 2024

Completion

Dec 31, 2024

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open label intervention

Primary Outcome Measure

Erythema Multiforme Flares on Medication [ Time Frame: 24 weeks ]

Locations (1)

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