Status:
COMPLETED
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Lead Sponsor:
Birken AG
Collaborating Sponsors:
University Hospital Tuebingen
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 invasi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00786994
Start Date
October 1 2008
End Date
November 1 2010
Last Update
September 14 2015
Active Locations (6)
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1
Charité University Hospital
Berlin, Germany
2
University Dermatology Hospital
Freiburg im Breisgau, Germany
3
University Dermatology Hospital
Tübingen, Germany
4
Dermatology practice
Wuppertal, Germany