Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003616

Trial Description

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Title

Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a
treatment period of 3 months will be tested. Additionally, once and twice daily applications
are tested.

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Brief Summary in Scientific Language

Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In
the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared
to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of
more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months
were reported. These encouraging results led to the present randomized, multicenter, double
blind phase II trial. The efficacy of the treatment shall be tested in a double blind
placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for
the planning of a phase III study.

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Organizational Data

  •   DRKS00003616
  •   2012/04/16
  •   2008/11/05
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00786994  (ClinicalTrials.gov)
  •   5006000  (Birken GmbH)
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Health Condition or Problem studied

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

  •   Drug: Oleogel-S-10
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance.; time frame: 18 weeks; Objective response of the marker actinic keratosis, defined as his-tologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.

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Secondary Outcome

- Histologically controlled complete clearance Histologically controlled downstaging 75 % clearance rate Dose response relationship Time to clinically complete response Tolerability; time frame: 18 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   [---]*
  •   2008/10/31
  •   165
  •   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

- At least two mild to moderate actinic keratoses located at the facial skin or the
head (except lips)

- Actinic keratoses with a diameter of 0,5 - 2 cm,

- that are definitely distinguished from other lesions and display a minimum
distance of 0,5 cm to neighbored lesions

- that are evaluated as histopathological grade 1 to 3

- histologically proven AK within three months before study entry

- prepared and able to give written informed consent

- ≥ 18 years of age

- In case of females: postmenopause defined as

- natural menopause with menses > 1 year ago

- serum FSH (> 20 IU/l) and E2 levels in the postmenopausal range or

- patients who had bilateral oophorectomy

- prepared and comply with all study requirements, including the following:

- application of Oleogel-S10 on the treatment area once or twice a day

- 4 clinic visits during the pre-study, treatment, post-treatment, and follow-up
period

- pre- and post-treatment biopsy for histological confirmation (of clearance) of
AK-diagnosis

- Representative histologic slide and tissue block were shipped

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Exclusion Criteria

- Active immunosuppressive therapy

- data of clinically significant, unstable, cardiovascular or hematologic, hepatic,
neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or
diseases Note: Patients with clinically stable medical conditions including, but not
limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia,
or osteoarthritis will be allowed to enter the study

- known allergies to any excipient in the study drug

- any dermatological disease and/or condition in the treatment or surrounding area (3
cm distances from treatment area) that may be exacerbated by treatment with
Oleogel-S-10 or cause difficulty with examination

- active chemical dependency or alcoholism, as assessed by the investigator

- pregnant and lactating women

- currently participating in another clinical study or have completed another clinical
study with an investigational drug within the past 30 days

- received topical treatment at the treatment area with diclofenac gel, imiquimod or
5-FU within a time period of 1 month

- Concomitant existence of non-treated (non-excised) basal cell carcinoma, squamous
cell carcinoma or malignant melanoma

- Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell
carcinoma, basal cell carcinoma, the latter is accepted if completely surgically
removed Note: A biopsy of any lesion within the treatment or surrounding area
suggestive of malignancy should be performed at the pre-study screening visit. If
invasive SCC or other malignant conditions are confirmed within the treatment area,
the patient will not be included in the study.

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Addresses

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    • Birken AG
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    • Universitätshautklinik Tübingen
    • Claus Garbe, Prof. Dr. 
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    • Universitätshautklinik Tübingen
    • Claus Garbe, Prof. Dr. 
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    •   [---]*
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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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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/11/01
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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 .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.