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

This study has been completed.
Sponsor:
Information provided by:
Birken AG
ClinicalTrials.gov Identifier:
NCT00786994
First received: November 5, 2008
Last updated: June 16, 2014
Last verified: January 2011
  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
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: Yes ]
    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.


Secondary Outcome Measures:
  • Histologically controlled complete clearance Histologically controlled downstaging 75 % clearance rate Dose response relationship Time to clinically complete response Tolerability [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

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 ointment for three months once a day (54 patients)
Drug: Oleogel-S10
topical use once or twice daily
Experimental: 2
Oleogel-S10 vehicle for three months twice a day (54 patients)
Drug: Oleogel-S10
topical use once or twice daily
Placebo Comparator: 3
Placebo (petroleum jelly) for three months once a day (27 patients)
Drug: Placebo (petroleum jelly)
Other Name: Vaseline
Placebo Comparator: 4
Placebo (petroleum jelly) for three months twice a day (27 patients)
Drug: Placebo (petroleum jelly)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Claus Garbe, Prof. Dr. Universitätshautklinik Tübingen
  More Information

No publications provided

Responsible Party: Birken GmbH
ClinicalTrials.gov Identifier: NCT00786994     History of Changes
Other Study ID Numbers: 5006000
Study First Received: November 5, 2008
Last Updated: June 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Birken AG:
Actinic Keratoses

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

ClinicalTrials.gov processed this record on October 29, 2014