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.
Conditions
Interventions
Product Name: Oleogel-S-10
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Triterpene dry extract from birch cork
Current Sponsor code: TE
Concentration unit: % percent
Concentration type
Sponsors
Birken GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Clinical clearance of all treated actinic keratoses;Secondary Objective: • Histologically controlled complete clearance of the marker actinic keratosis • Histologically controlled downstaging of the grading of the marker actinic keratosis • 75 % clearance rate of the treated actinic keratoses • Dose response relationship for once and twice daily treatments • Time to clinically complete response • Tolerability as assessed by investigator and by the patient ;Primary end point(s): The primary end point is clinical clearance of all treated actinic keratoses | — |
Countries
Germany
Outcome results
None listed