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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Birken AG
• Collaborator: University Hospital Tuebingen
• Treatments: Petrolatum

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.