Neurokinin-1 Receptor Antagonist for the Treatment of Itch in EB Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Allergy, Skin and Soft Tissue Infections |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Otolaryngology |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 11/3/2018 |
| Start Date: | August 31, 2016 |
| End Date: | February 2019 |
A Phase 2 Trial of Neurokinin-1 Receptor Antagonist for the Treatment of Itch in Epidermolysis Bullosa Patients
Our goal is to determine whether daily oral administration of VPD-737 (5 mg) is effective and
safe in adolescents and adults with Epidermolysis Bullosa (EB).
safe in adolescents and adults with Epidermolysis Bullosa (EB).
Itch is the most common complaint reported by patients with EB of all subtypes, and there is
no current effective treatment. Itch often triggers scratching that creates new wounds and
increases EB disease severity. This study aims to target the physiological mechanisms of
pruritus (itch) in patients with EB .
Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 (NK1),
which is expressed in the central nervous system and the skin.
VPD-737 (serlopitant), a novel drug that inhibits the NK1 receptor, has been shown to reduce
severe itch in a previous study of 257 adult patients with chronic pruritus.
The investigators are now testing VPD-737 in 14 patients with EB in a Phase II randomized,
placebo-controlled, double-blinded clinical trial.
no current effective treatment. Itch often triggers scratching that creates new wounds and
increases EB disease severity. This study aims to target the physiological mechanisms of
pruritus (itch) in patients with EB .
Substance P is a major mediator of pruritus and binds to the receptor neurokinin-1 (NK1),
which is expressed in the central nervous system and the skin.
VPD-737 (serlopitant), a novel drug that inhibits the NK1 receptor, has been shown to reduce
severe itch in a previous study of 257 adult patients with chronic pruritus.
The investigators are now testing VPD-737 in 14 patients with EB in a Phase II randomized,
placebo-controlled, double-blinded clinical trial.
Inclusion Criteria:
- Clinical diagnosis of epidermolysis bullosa and pruritus
Exclusion Criteria:
- Have chronic liver or renal disease
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