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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786994
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : August 14, 2015
Last Update Posted : September 14, 2015
University Hospital Tuebingen
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )

Tracking Information
First Submitted Date  ICMJE November 5, 2008
First Posted Date  ICMJE November 6, 2008
Results First Submitted Date  ICMJE April 2, 2015
Results First Posted Date  ICMJE August 14, 2015
Last Update Posted Date September 14, 2015
Study Start Date  ICMJE October 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
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 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
Clinical clearance of all treated actinic keratoses [ Time Frame: 18 weeks ]
Change History Complete list of historical versions of study NCT00786994 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
Histologically controlled complete clearance Histologically controlled downstaging 75 % clearance rate Dose response relationship Time to clinically complete response Tolerability [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratoses
Intervention  ICMJE
  • Drug: Oleogel-S10 100 mg/g
    topical use once or twice daily
  • Drug: Placebo (petroleum jelly)
    topical use once or twice daily
    Other Name: Vaseline
Study Arms  ICMJE
  • Experimental: 1
    Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)
    Intervention: Drug: Oleogel-S10 100 mg/g
  • Experimental: 2
    Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)
    Intervention: Drug: Oleogel-S10 100 mg/g
  • Placebo Comparator: 3
    Placebo (petroleum jelly) for three months once a day (27 patients)
    Intervention: Drug: Placebo (petroleum jelly)
  • Placebo Comparator: 4
    Placebo (petroleum jelly) for three months twice a day (27 patients)
    Intervention: Drug: Placebo (petroleum jelly)
Publications * Pflugfelder A, Andonov E, Weide B, Dirschka T, Schempp C, Stockfleth E, Stratigos A, Krüger-Krasagakis S, Bauer J, Garbe C, Eigentler TK. Lack of activity of betulin-based Oleogel-S10 in the treatment of actinic keratoses: a randomized, multicentre, placebo-controlled double-blind phase II trial. Br J Dermatol. 2015 Apr;172(4):926-32. doi: 10.1111/bjd.13342. Epub 2015 Feb 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Greece
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00786994
Other Study ID Numbers  ICMJE BAK-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amryt Pharma ( Birken AG )
Study Sponsor  ICMJE Birken AG
Collaborators  ICMJE University Hospital Tuebingen
Investigators  ICMJE
Principal Investigator: Claus Garbe, Prof. Dr. Universitätshautklinik Tübingen
PRS Account Amryt Pharma
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP