chronic pruritus in patients suffering from prurigo Acute pruritus in itching models Healthy volunteers L28.2
Conditions
Interventions
Group 1: The study has two different parts. In the first part, the relationship between blood flow and acute itching is determinate in healthy volunteers. We will induce acute pruritus in healthy volu
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria healthy subjects: The volunteers must be over eighteen, and be able to communicate with the investigator. They must be able to understand the contents of the study and they need to consent to participate in the study. Only male subjects. Inclusion criteria patients: 1. Signed informed consent 2. Prurigo patients with chronic pruritus (> 6 months) and a severity of prurigo using VAS = 6/10 3. The patient willing to only use the mentioned products and no other own externa. As rescue medication in severe itching, patients receive a care cream DAC base cream that can be applied as often as desired. 4. Of full age 5. Both male and female patients
Exclusion criteria
Exclusion criteria: Exclusion criteria subjects: Known history of hypersensitivity to any of the substances to be applied. Regular or current intake of medications against itch such as antihistamines, topical or systemic steroids, immunosuppressants or gabapentin. Participation in a clinical trial in the last 30 days. Exclusion criteria patients: 1. Therapeutic UV radiation during the last 6 weeks before the start of the investigation or during the investigation 2. Topical antihistamines, steroids or mast cell stabilizers in the last 3 weeks prior to the study or during the study 3. Systemic medications such antihistamnika, antidepressants, antipsychotics, corticosteroids are permitted if: a) the medication were taken since at least the last 4 weeks prior to the study and b) there has been no changes regarding the use or dosage during the study 4. A history of hypersensitivity to any of the substances to be applied 5. Diseases that does not allow to include patients in the study, assessed by the investigator 6. Pregnant or lactating women or planned pregnancies during the study 7. Participation in another study in the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of blood circulation unter propranolol using Laser- Speckle- method (before and after application over a period of four weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Reduction of pruritus under propranolol using NRS (before and after application over a period of four weeks) -Reduction of volumetric measurements under propranolol using PRIMOS (before and after application over a period of four weeks) -Reduction of patient global assessment under propranolol (before and after application over a period of four weeks) -Reduction of severity score under propranolol (before and after application over a period of four weeks) | — |
Countries
Germany
Contacts
Public ContactNicole Schoepke
Charité - Universitätsmedizin Berlin
Outcome results
None listed