Trial document





This trial has been registered retrospectively.
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  DRKS00000491

Trial Description

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Title

Placebo controlled, prospective observation of pain perception of participants during mechanical epilation with the Braun Expressive Epilator after application of topical medication (Emla cream, cream containing polidocanol)

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Trial Acronym

CRIES

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this clinical examination is to research the perception of pain during mechanical epilation in healthy volunteers . It is yet unknown to what extend and after what kind of application time the pain during the use of a mechanically working epilation devices is influenced positively by other pain influencing therapies, e.g. pre-treatment with topical medication (drugs externally applied on the skin, they are applied on the part of the skin where they are supposed be therapeutically effective). Furthermore, it will be researched if the pre-treatment with topical medication influences different parts of the skin (legs, axilla) in a different way in their perception of pain. As it is sufficiently proven that Emla cream and creams containing polidocanol have positive effects on the perception of pain, that means that one feels less pain, they will be used as topical medication in this study. Both drugs are approved in Germany.
This study will compare Emla cream or a cream containing polidocanol to a placebo.

There will be three groups:

1. Comparison of Emla and placebo on the lower leg (inner and outer side), on every lower leg (inner/outer) two stripes (size: approx. 40 cm²)
2. Comparison of 10% Policanol cream and placebo on the lower leg (inner and outer side), one on every lower leg , two stripes (size: approx. 40 cm²)
3. Comparision of Emla and placebo on the axilla, 30 minutes per axilla, one stripe (max. size: 100cm²)

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Brief Summary in Scientific Language

There have been a lot of reports in pain research in recent years. The effects of both Emla and Polidocanol are well known and assured in many studies. Studies about pain reduction during dermal injections and laser applications let assume that the pain occurring during the application of an epilation device can be reduced considerably.
One difficulty could be the necessary penetration depth of the substance of several millimetres. In literature, it was stated that at the extraction of biopsy material with topically, occlusively applied Emla cream an application time of 2 h is needed to achieve a significant pain reduction in a depth of 3mm. This penetration depth is necessary for hair removal at the root because of papilla being 2-4mm deep in the skin. After an application time of 1h, a pain reduction of 50% during the dermal injection is stated. The same pain reduction is achieved for hair removal with laser. It is yet unknown to what extend and after what time of application the pain during the use of a mechanically working epilation device, which already reduces pain perception due to its specific effect on the mechanoreceptors, can also be influenced by other pain influencing treatments. Furthermore, it will be researched if epilation of different parts of the skin (legs, axilla) results in a different extend of pain reduction during the epilation.
A lot of topical medication used as antipruritic and/or topical anesthetic contains polidocanol. A 5-10% magistral formula is available at the NRF (Neues Rezeptur-Formularium). It has different effects than topical anesthetics used for symptomatic treatment of superficial dermatitis and pruriti on different levels of genesis.

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Organizational Data

  •   DRKS00000491
  •   2010/11/10
  •   [---]*
  •   yes
  •   Approved
  •   837.176.10(7185), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1116-1604 
  •   2010-019715-38 
  •   4036349 
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Health Condition or Problem studied

  •   R52.9 -  Pain, unspecified
  •   Pain perception of test persons after the application of topical medication during mechanical epilation
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Interventions/Observational Groups

  •   Emla cream versus placebo, EMLA cream is on the first leg outer side and innner side placebo applied and on the other leg outer side placebo and inner side Emla cream. The area which is treated on the innner side or outer side of a leg, is 20 cm ². The dose is 3 g of EMLA Cream per 20 cm ² area of skin at an exposure of 1 or 2 hours. Here, the EMLA and placebo cream is first applied to the area where the Emla or a placebo has to be left on for two hours.
  •   cream containing polidocanol versus placebo, cream containing polidocanol is on the first leg outer side and inner side placebo applied and on the other leg outer side placebo and inner side cream
    containing polidocanol . The area which is treated on the inner side or outer side of a leg, is 20 cm ². The dose is 3 g of Cream containing polidocanol per 20 cm ² area of skin at an exposure of 1 hours or 30 minutes. Here, the cream containing polidocanol and placebo cream is first applied to the area where the cream containing polidocanol or a placebo has to be left on for one hour.
  •   Emla cream versus placebo, axilla, the area which is treated is 20 cm ². The dose is 3 g of EMLA Cream per 20 cm ² area of skin with an exposure time of 30 minutes.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Other
  •   II
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Primary Outcome

The primary aim is the subjective assessment of pain perception after the application of Emla cream and cream containing polidocanol versus placebo directly after mechanical epilation by visual analogue scale (VAS).

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Secondary Outcome

• Evaluation of the pressure sensation using of Frey hairs (in order of von Frey hairs after rising mechanical stimulus) of the test persons before and after the use of the externa (Emla cream or polidocanol-containing cream)
• Evaluation of cold sensation with aluminum rod and VAS before and after application of the externa (Emla cream or polidocanol-containing cream)
• Examination of safety and tolerance of the applikation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/08/18
  •   54
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

•Female, full age participants between 18 and 35
•Participants have to have a pelage of at least 2mm in the skin area which is supposed to be treated
•Test 1,2: these tests are carried out with people who regularly use wet or dry shavers (last shaving approx. 2 weeks ago)
•Test 3: this test can be done by both participants who shave (last shaving approx. 2 weeks ago) and participants preferring epilation and hair removal methods using wax
•A personally signed informed consent of the participant has to be available before any kind of examination specific action is performed
•The participant is capable of consent
•The participant is able to understand nature, scope and the individual consequences of the clinical trial
•The participant is able to document their written consent to the study

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Exclusion Criteria

•Serious diseases, especially of the immune system ( e.g. HIV, Hepatitis infection)
•Tumordiseases
•Epilepsy
•Pregnancy and breast feeding women
•UV irradiation on the day of the epilation
•Histamine antagonists
•Treatment with corticosteroids or medication which influences pain receptions up to 48h before the epilation (internal and topical)
•Bleeding disorder, present therapies with anticoagulants (e.g. Marcumar)
•known intolerance to the substances which are supposed to be applied and/or the disinfectant
•Intolerance to the investigational medical product or to another chemical substance or to one element of the investigational medical product
•Participation in another clinical trial during or within 3 months before this clinical examination
•Medical or psychological circumstances which threaten the proper realization of the clinical examination
•Menstruation at the time of the epilation

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Addresses

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    • Hautklinik und Poliklinik Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr. med.  Petra  Staubach-Renz 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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    • Hautklinik und Poliklinik Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr. med.  Petra  Staubach-Renz 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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    • Hautklinik und Poliklinik Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Ms.  Dr. med.  Petra  Staubach-Renz 
    • Langenbeckstr.1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Braun GmbH
    • Mr.  Frieder A.   Grieshaber 
    • Frankfurter Strasse 145
    • 61476  Kronberg im Taunus
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.