Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009525

Trial Description

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Title

Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a phase 4, multi-centre, randomized, two group, open label, active controlled,
parallel group, 17 week trial.

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Brief Summary in Scientific Language

All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and
discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.

Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:

- Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for
the first treatment course. At 8 weeks after treatment initiation, subjects who present
with existing AKs or newly emergent AKs in the treatment area will receive one more
treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.

- Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

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Organizational Data

  •   DRKS00009525
  •   2015/11/13
  •   2015/03/27
  •   no
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Secondary IDs

  •   NCT02406014  (ClinicalTrials.gov)
  •   LP0041-1120  (LEO Pharma)
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Health Condition or Problem studied

  •   Actinic Keratosis (AK)
  •   L57.0 -  Actinic keratosis
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Interventions/Observational Groups

  •   Drug: Ingenol Mebutate Gel, 0.015%
  •   Drug: Diclofenac sodium gel 3%
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- Complete clearance of all AKs; time frame: 11 Months; Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%

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Secondary Outcome

- Complete clearance of all AKs at Week 17; time frame: 11 Months; As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with complete clearance in the ingenol mebutate 0.015% group.

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Countries of Recruitment

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Locations of Recruitment

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Recruitment

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  •   2015/04/30
  •   500
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Inclusion Criteria

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

1. Following verbal and written information about the trial, subject must provide
informed consent documented by signing the Informed Consent Form (ICF) prior to any
trial related procedures

2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous
25 cm² treatment area on the face or scalp

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Exclusion Criteria

1. Location of the selected treatment area:

- on the periorbital skin

- on the perioral skin/around the nostrils

- within 5 cm of an incompletely healed wound

- within 10 cm of a suspected BCC or SCC or other neoplasia

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Addresses

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    • LEO Pharma
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    • St. Josef-Hospital im Katholischen Klinikum Bochum
    • Eggert Stockfleth, Prof.Dr.med. 
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    • Claudia Miranda Foca-Fuchs, M.Sc. 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2015/10/13
* This entry means the parameter is not applicable or has not been set.