Prurigo nodularis Skin and Connective Tissue Diseases Prurigo nodularis
Conditions
Interventions
The tested product is a cream containing purified omental lipid, polidocanol, PEA (palmitoylethanolamide). The trial will involve 2 weeks of treatment with a total of three visits (at baseline and aft
Sponsors
Difa Cooper (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 60 years 2. Men and women 3. Clinical diagnosis of prurigo nodularis affecting at least both arms
Exclusion criteria
Exclusion criteria: 1. Acute or chronic skin conditions characterized by itching (with the exclusion of prurigo nodularis) 2. Medical internal conditions characterized by chronic itching (renal insufficiency, chronic liver disease, haematological conditions like lymphoma, polycythemia etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of itch sensation at baseline and week 2 using: 1. Pruritus Visual Analogue Scale (0-100 mm) (P-VAS), a mono-dimensional scale for assessment of itch intensity 2. Numerical Rating Scale (NRS) from 1 to 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Grade of acanthosis measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 2. Hyperkeratosis measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 3. Vascular signal measured using Optical Coherence Tomography (Vivascope UK) device at baseline and week 2 | — |
Countries
Italy
Contacts
Public ContactMassimo Milani
Outcome results
None listed