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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00786994
First Posted: November 6, 2008
Last Update Posted: September 14, 2015
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.
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
Amryt Pharma ( Birken AG )
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Amryt Pharma ( Birken AG ):

Primary Outcome Measures:
  • 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.



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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786994


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

Publications:
Responsible Party: Birken AG
ClinicalTrials.gov Identifier: NCT00786994     History of Changes
Other Study ID Numbers: BAK-08
First Submitted: November 5, 2008
First Posted: November 6, 2008
Results First Submitted: April 2, 2015
Results First Posted: August 14, 2015
Last Update Posted: September 14, 2015
Last Verified: August 2015

Keywords provided by Amryt Pharma ( Birken AG ):
Actinic Keratoses

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Petrolatum
Emollients
Dermatologic Agents