Conditions: Primary Erythromelalgia Inherited Erythromelalgia
Keywords: IEM EM Erythromelalgia Erythermalgia Red neuralgia Peripheral Vascular Disease Vascular Disease Cardiovascular Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 8
Healthy volunteers: no

Brief summary:
This is a Phase 2a single-center, randomized, double-blind, Placebo-controlled, parallel group study with XPF-002 applied twice daily over 14 or 21 days in patients with Primary/Inherited Erythromelalgia (IEM). The purpose of this study is to determine whether XPF-002 is safe and effective in the treatment of pain caused by IEM.

Detailed description:
Your role in the study would include:

* Travelling to the clinic (in Anniston, Alabama, USA) for 3 out-patient visits, each lasting approximately 1 day
* Travelling and staying in the clinic for 2 in-patient stays:
* For the first in-patient visit you will have to spend 8 days and 7 nights in the clinic
* For the second in-patient visit you will have to spend 2 days and 1 night in the clinic You can bring books, laptops and DVDs to the clinic.

If you do not live within driving distance to the clinic you will need to stay in the local area (in Anniston, at a local hotel) for 1 to 2 weeks while you use the ointment, in addition to the in-patient portion of the study.

Arms:
arm 1: XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days arm 2: XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.

Interventions: intervention 1: XPF-002 intervention 2: Placebo
Intervention descriptions: intervention 1: XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days intervention 2: XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.

Protocol document: