Know Cancer

or
forgot password

Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial


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 invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of
more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months
were reported. These encouraging results led to the present randomized, multicenter, double
blind phase II trial. The efficacy of the treatment shall be tested in a double blind
placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for
the planning of a phase III study.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance.

Outcome Description:

Objective response of the marker actinic keratosis, defined as his-tologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.

Outcome Time Frame:

18 weeks

Safety Issue:

Yes

Principal Investigator

Claus Garbe, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätshautklinik Tübingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

5006000

NCT ID:

NCT00786994

Start Date:

October 2008

Completion Date:

November 2010

Related Keywords:

  • Actinic Keratoses
  • Actinic Keratoses
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location