Overview

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.