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

August 30, 2015 updated by: Birken AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite University Hospital
      • Freiburg, Germany
        • University Dermatology Hospital
      • Tübingen, Germany
        • University Dermatology Hospital
      • Wuppertal, Germany
        • Dermatology Practice
  • Greece
      • Athens, Greece
        • National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
      • Heraklion, Greece
        • University Dermatology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Vaseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Birken AG

Collaborators

University Hospital Tuebingen

Investigators

  • Principal Investigator: Claus Garbe, Prof. Dr., Universitätshautklinik Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

August 30, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAK-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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