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

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oleogel-S10 100 mg/g
Placebo (petroleum jelly)
Sponsored by
Birken AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Charité University Hospital
  • University Dermatology Hospital
  • University Dermatology Hospital
  • Dermatology practice
  • National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
  • University Dermatology Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)

Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)

Placebo (petroleum jelly) for three months once a day (27 patients)

Placebo (petroleum jelly) for three months twice a day (27 patients)

Outcomes

Primary Outcome Measures

Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2008
Last Updated
August 30, 2015
Sponsor
Birken AG
Collaborators
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00786994
Brief Title
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birken AG
Collaborators
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Actinic Keratoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)
Arm Title
2
Arm Type
Experimental
Arm Description
Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo (petroleum jelly) for three months once a day (27 patients)
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo (petroleum jelly) for three months twice a day (27 patients)
Intervention Type
Drug
Intervention Name(s)
Oleogel-S10 100 mg/g
Intervention Description
topical use once or twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo (petroleum jelly)
Other Intervention Name(s)
Vaseline
Intervention Description
topical use once or twice daily
Primary Outcome Measure Information:
Title
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Garbe, Prof. Dr.
Organizational Affiliation
Universitätshautklinik Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Hospital
City
Berlin
Country
Germany
Facility Name
University Dermatology Hospital
City
Freiburg
Country
Germany
Facility Name
University Dermatology Hospital
City
Tübingen
Country
Germany
Facility Name
Dermatology practice
City
Wuppertal
Country
Germany
Facility Name
National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
City
Athens
Country
Greece
Facility Name
University Dermatology Hospital
City
Heraklion
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
25124939
Citation
Pflugfelder A, Andonov E, Weide B, Dirschka T, Schempp C, Stockfleth E, Stratigos A, Kruger-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.
Results Reference
result

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

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