Randomized, multicenter, double blind study to compare the efficacy and tolerability of Oleogel-S-10 for 3 months versus placebo only in patients with mild to moderate ac-tinic keratoses located at the face and head - BETA-Trial
- Conditions
- Die Studie ist eine randomisierte, multizentrische, doppelt verblindete Studie zum Vergleich der Wirksamkeit und Verträglichkeit einer Behandlung mit Oleogel-S-10 über 3 Monate vs. Placebo bei Patienten mit gering- bis mittelgradigen aktinischen Keratosen des Kopfes inkl. des Gesichtes. Ziel der Studie ist es, die Wirksamkeit und die Tolerabilität dieser Behandlung zu prüfen.
- Registration Number
- EUCTR2008-002632-15-DE
- Lead Sponsor
- Birken GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 162
•At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips)
•histologically proven AK within three months before study entry.
•prepared and able to give written informed consent
•= 18 years of age
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Active immunosuppressive therapy
•data of clinically significant, unstable, cardiovascular or haematologic, 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 os-teoarthritis 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
•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
•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 pa-tient will not be included in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •Clinical clearance of all treated actinic keratoses;Secondary Objective: •Histologically controlled complete clearance of the marker actinic keratosis<br>•Histologically controlled downstaging of the grading of the marker actinic keratosis<br>•75 % clearance rate of the treated actinic keratoses<br>•Dose response relationship for once and twice daily treatments<br>•Time to clinically complete response<br>•Tolerability as assessed by investigator and by the patient<br>;Primary end point(s): The primary end point is clinical clearance of all treated actinic keratoses
- Secondary Outcome Measures
Name Time Method