Trial document




drksid header

  DRKS00008764

Trial Description

start of 1:1-Block title

Title

Characterization of the role of blood circulation and neovascularization in acute and chronic pruritus

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

iETOP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is the identification and characterization of the importance of increased blood circulation and neovascularization in patients with chronic pruritus and in experimental models of acute induced pruritus in healthy volunteers.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The present trial has the aim to verify the following hypotheses:
1. Various models of experimental induction of pruritus on healthy lead to increased capillary blood flow.
2. Reduction of blood flow at the site of itching reduce the severity of pruritus in healthy volunteers
3. Patients with prurigo (chronic pruritus with secondary scratch lesions) have an increased vascularity at the site of the itching
4. Local reduction of blood flow and possibly of neovascularization reduce severity of pruritus in patients suffering from prurigo

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008764
  •   2015/07/10
  •   [---]*
  •   yes
  •   Approved
  •   EA4/103/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1171-1359 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   chronic pruritus in patients suffering from prurigo
  •   Acute pruritus in itching models
  •   L28.2 -  Other prurigo
  •   Healthy volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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 volunteers by using different models, including skin prick test on the forearm.
    Blood flow using laser speckle method, pruritus using NRS and diameter of wheal and/or erythema will be determinate in these provoked areas.
    The effect of locally applied brimonidine and propranolol will be assess.
  •   In a second part of the study, the relationship between blood flow and chronic pruritus will be evaluate in patients suffering from prurigo.
    Pruritus using NRS and blood flow using laser speckle method will be assess in affected skin areas. The short-term effect of topical applicate brimonidine and propranolol on the above-mentioned factors will be determinate. We are looking for the medium- and longer-term effects by topical application of Propranolol in over four weeks. We will determinate blood flow by laser speckle method, the pruritus by NRS and we do a score for severity of erythema, crusts, scratching and infiltration. A three-dimensional image of the skin surface before and after application will be done in order to detect possible changes. In addition to an optional new innovative skin micro biopsy will be perform.
  •   For evaluation of the medium- and longer-term effects the Patient will receive a vehicel for a index leasion over four weeks. We will determinate blood flow by laser speckle method, the pruritus by NRS and we do a score for severity of erythema, crusts, scratching and infiltration. A three-dimensional image of the skin surface before and after application will be done in order to detect possible changes. In addition to an optional new innovative skin micro biopsy will be perform.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   Yes
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Reduction of blood circulation unter propranolol using Laser- Speckle- method (before and after application over a period of four weeks)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

-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)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/07/31
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité - Universitätsmedizin Berlin
    • Mr.  Professor  Martin  Metz 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité - Universitätsmedizin Berlin
    • Mr.  Professor  Martin  Metz 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité - Universitätsmedizin Berlin
    • Ms.  Dr. med.  Nicole  Schoepke 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.