Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003719

Trial Description

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Title

Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in
treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging
in a previously cleared field.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003719
  •   2012/09/28
  •   2012/05/14
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2011-005018-13 
  •   NCT01600014  (ClinicalTrials.gov)
  •   LP0041-22  (LEO Pharma)
  •   2011-005018-13 
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Health Condition or Problem studied

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

  •   Drug: Ingenol mebutate gel, 0.015%
  •   Drug: Vehicle gel
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Complete clearance of AKs; time frame: 8 weeks after randomisation; The complete clearance rates 8 weeks after randomisation will be compared between ingenol mebutate gel, 0.015% and vehicle gel.

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Secondary Outcome

- Complete clearance of AKs; time frame: at month 12; The complete clearance rate in the selected treatment area through to Month 12
- Change in AK counts; time frame: 8 weeks after randomisation; Change in AK counts in the selected treatment area from randomisation to 8 weeks after randomisation

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Countries of Recruitment

  •   Australia
  •   Canada
  •   Germany
  •   France
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

  •   Planned
  •   2012/05/31
  •   454
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Subjects must provide informed consent

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

- Subject at least 18 years of age

- Female subjects must be of either:

- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
history of sterility (e.g. the subject is without a uterus) or,

- Childbearing potential, provided there is a confirmed negative urine pregnancy
test prior to study treatment, to rule out pregnancy

- Female subjects of childbearing potential must be willing to consent to using highly
effective methods of contraception

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Exclusion Criteria

- Location of the selected treatment area:

- on any location other than the face or scalp

- on the periorbital skin

- within 5 cm of an incompletely healed wound

- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell
carcinoma (SCC)

- Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on
trunk and extremities acceptable)

- Selected treatment area lesions that have atypical clinical appearance

- History or evidence of skin conditions other than the trial indication that would
interfere with evaluation of the trial medication in the selected treatment area

- Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the
first treatment cycle

- Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

- Presence of sunburn within the selected treatment area

- Current enrollment or participation in a clinical trial within 30 days of entry into
this study

- Subjects previously entered first treatment in the trial

- Female subjects who are breastfeeding

- Subjects who are institutionalised by court order or by the local authority

- In the opinion of the investigator, the subject is unlikely to comply with the
Clinical Study Protocol

Prohibited Therapies and/or Medications within 2 weeks prior to Day 1

- Cosmetic or therapeutic procedures within 2 cm of the selected treatment area

- Use of keratolytic topical therapeutic products within 2 cm of the selected treatment
area

- Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm
of the selected treatment area; artificial tanners: within 5 cm of the selected
treatment area

Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1

- Treatment with immunomodulators, cytotoxic drugs or interferon /interferon inducers

- Treatment with systemic medications that suppress the immune system

- Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)

Prohibited Therapies and/or Medications within 8 weeks prior to Day 1

- Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic
therapy: within 2 cm of the selected treatment area

Prohibited Therapies and/or Medications within 6 months prior to Day 1

- Use of systemic retinoids or biologic/monoclonal antibody therapies

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Addresses

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    • LEO Pharma
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    •   [---]*
    •   [---]*
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    • University Hospital Tuebingen
    • Claus Garbe, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • University Hospital Tuebingen
    • Claus Garbe, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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 .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.