Trial document

This study has been imported from without additional data checks.
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Trial Description

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Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%. A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial

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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 compare the risk of developing squamous skin cancer (SCC) or
other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream.
Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive
a second treatment cycle with the same treatment if the first treatment does not clear all
AKs. Subjects will be followed over a period of three year (36 months) after first treatment

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Brief Summary in Scientific Language


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Organizational Data

  •   DRKS00006728
  •   2014/11/07
  •   2013/08/19
  •   no
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Secondary IDs

  •   2012-003112-31 
  •   NCT01926496  (
  •   LP0041-63  (LEO Pharma)
  •   2012-003112-31 
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Health Condition or Problem studied

  •   Actinic Keratosis (AK)
  •   L57.0 -  Actinic keratosis
  •   C44 -  Other malignant neoplasms of skin
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Interventions/Observational Groups

  •   Drug: Ingenol Mebutate Gel, 0.015%
  •   Drug: Imiquimod Cream, 5%
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  •   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

- Incidence of SCC; time frame: 3 years; To compare the cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.
The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.

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Secondary Outcome

- Incidence of neoplasia; time frame: 12 months; To compare the cumulative incidence of neoplasia and the short-term and 12-month efficacy of ingenol mebutate gel with imiquimod cream.

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Countries of Recruitment

  •   France
  •   Germany
  •   United Kingdom
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Locations of Recruitment

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  •   2013/09/30
  •   480
  •   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

1. Signed Informed Consent Form (ICF) prior to any trial-related procedures

2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous
25 cm² treatment area on the face or scalp.

3. Subject at least 18 years of age

4. Female subjects must be of either:

1. Non-childbearing potential, or,

2. Childbearing potential, provided there is a confirmed negative urine pregnancy

5. Female subjects of childbearing potential must be willing to use highly effective
methods of contraception (Pearl index < 1%)

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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

2. Selected treatment area lesions that have atypical clinical appearance (e.g.,
hypertrophic, hyperkeratotic or cutaneous horn).

3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment

4. 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

5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment
area within 2 years prior to Screening (Visit 1)

6. Organ transplant recipients

7. Immunosuppressed subjects (for example HIV patients)

8. Female subjects who are breastfeeding.

9. Subjects who are institutionalised by court order or by the local authority

10. In the opinion of the investigator, the subject is unlikely to comply with the
Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

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  • start of 1:1-Block address primary-sponsor
    • LEO Pharma
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    • Klinik für Dermatologie und Allergologie
    • Rolf- Markus Szeimies, Professor, Dr. med. 
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    • Maj Britt Larsen, ICTM 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   47
  •   2014/09/08
* This entry means the parameter is not applicable or has not been set.