Trial document





This trial has been registered retrospectively.
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  DRKS00004969

Trial Description

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Title

Efficacy of Actikerall® in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical treatment. Additional aspects to be investigated are clinical development of lesions under therapy and after termination of Actikerall® therapy as well as patients´ satisfaction and handling of Actikerall®. Study population consists of patients, who had recently been adjusted to Actikerall® therapy. One optional check-up examination is intended under treatment with Actikerall®. On terminating therapy, Actikerall® is to be assessed on a routine basis. Actikerall® therapy is to be finally assessed about eight weeks but no more than 22 weeks after termination of therapy. Patients will be handed out a patient questionnaire regarding satisfaction and handling of Actikerall®.

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Brief Summary in Scientific Language

Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical treatment. Additional aspects to be investigated are clinical development of lesions under therapy and after termination of Actikerall® therapy as well as patients´ satisfaction and handling of Actikerall®. Study population consists of patients, who had recently been adjusted to Actikerall® therapy. One optional check-up examination is intended under treatment with Actikerall®. On terminating therapy, Actikerall® is to be assessed on a routine basis. Actikerall® therapy is to be finally assessed about eight weeks but no more than 22 weeks after termination of therapy. Patients will be handed out a patient questionnaire regarding satisfaction and handling of Actikerall®.

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Organizational Data

  •   DRKS00004969
  •   2013/05/15
  •   [---]*
  •   no
  •   Approved
  •   129/2012, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Actinic keratosis
  •   L57.0 -  Actinic keratosis
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Interventions/Observational Groups

  •   Study population consists of patients, who had recently been adjusted to Actikerall® therapy in routine medical practice due to actinic keratosis (clinical grade I or II according to Olsen). One optional check-up examination is intended under treatment with Actikerall®. On terminating therapy, Actikerall® is to be assessed on a routine basis. Actikerall® therapy is to be finally assessed about eight weeks but no more than 22 weeks after termination of therapy. Patients will be handed out a patient questionnaire regarding satisfaction and handling of Actikerall®.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Description of efficacy of Actikerall® therapy in patients with actinic keratosis (clinical grade I or II according to Olsen) in relation to treatment duration in routine medical treatment.
Matter of particular interest are clinical changes in lesions under therapy with Actikerall® and beyond end of therapy. Measured values are current findings (total number, mean size (in mm) and changes in lesions determined by clinical examination and physician´s assessment of Actikerall® (efficacy, tolerance and patient compliance) by means of scales. Values are measured at baseline examination, optional interim examination, final examination (at end of therapy) and final assessment (about eight weeks after final examination). Collected data is documented in a standardized CRF-form.

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Secondary Outcome

Additional end-point to be investigated are duration of therapy under Actikerall® (mean duration of therapy) as well as patients´ satisfaction and handling of Actikerall® determined by means of a standardized questionnaire. The questionnaire is handed out to the patient for completion at baseline examination and will be returned at the respective following examination.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2013/02/18
  •   1650
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Enrolled patients are to be immune-competent, adult patients suffering from actinic keratosis (clinical stage I or II according to Olsen), who are to be treated with Actikerall® based upon physicians´ therapeutic decision.

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Exclusion Criteria

*hypersensitivity to fluorouracil or salicylic acid
*planned or existing pregnancy or nursing period
*renal insufficiency
*(pre-)medication containing brivudine, sorivudine or analogs, that has been terminated less than four weeks prior to therapy start with Actikerall®
*immune suppression

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Addresses

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    • Almirall Hermal GmbH
    • Mr.  Dr. med.  Andreas  Prechtl 
    • Scholtzstraße 3
    • 21465  Reinbek
    • Germany
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    •   [---]*
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    • Centroderm GmbH,
    • Mr.  Prof. Dr. med.  Thomas  Dirschka 
    • Schuchardstr. 15
    • 42275  Wuppertal
    • Germany
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    • Almirall Hermal GmbH
    • Ms.  Antje  Melzer 
    • Scholtzstraße 3
    • 21465  Reinbek
    • Germany
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    • ANFOMED GmbH
    • Ms.  Ursula  Burkard 
    • Röttenbacher Straße 17
    • 91096  Möhrendorf
    • Germany
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Sources of Monetary or Material Support

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    • Almirall Hermal GmbH
    • Mr.  Dr. med.  Andreas  Prechtl 
    • Scholtzstraße 3
    • 21465  Reinbek
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/10
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Trial Publications, Results and other Documents

  •   U. Reinhold, I. Hadshiew, A. Melzer, A. Prechtl, Low-dose 5-fluorouracil in combination with salicylic acid for the treatment of actinic keratoses on the hands and/or forearms – results of a non-interventional study, JEADV 2016, DOI: 10.1111/jdv.13935
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* This entry means the parameter is not applicable or has not been set.