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The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

This study has been completed.
University Hospital Tuebingen
Information provided by (Responsible Party):
Birken AG Identifier:
First received: November 5, 2008
Last updated: August 30, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Actinic Keratoses
Drug: Oleogel-S10 100 mg/g
Drug: Placebo (petroleum jelly)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Birken AG:

Primary Outcome Measures:
  • Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

    Objective response of the marker actinic keratosis, defined as histologically 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.

    The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.

Enrollment: 165
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)
Drug: Oleogel-S10 100 mg/g
topical use once or twice daily
Experimental: 2
Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)
Drug: Oleogel-S10 100 mg/g
topical use once or twice daily
Placebo Comparator: 3
Placebo (petroleum jelly) for three months once a day (27 patients)
Drug: Placebo (petroleum jelly)
topical use once or twice daily
Other Name: Vaseline
Placebo Comparator: 4
Placebo (petroleum jelly) for three months twice a day (27 patients)
Drug: Placebo (petroleum jelly)
topical use once or twice daily
Other Name: Vaseline

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00786994

Charité University Hospital
Berlin, Germany
University Dermatology Hospital
Freiburg, Germany
University Dermatology Hospital
Tübingen, Germany
Dermatology practice
Wuppertal, Germany
National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
Athens, Greece
University Dermatology Hospital
Heraklion, Greece
Sponsors and Collaborators
Birken AG
University Hospital Tuebingen
Principal Investigator: Claus Garbe, Prof. Dr. Universitätshautklinik Tübingen
  More Information

Responsible Party: Birken AG Identifier: NCT00786994     History of Changes
Other Study ID Numbers: BAK-08 
Study First Received: November 5, 2008
Results First Received: April 2, 2015
Last Updated: August 30, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Birken AG:
Actinic Keratoses

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Dermatologic Agents processed this record on October 21, 2016