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

NCT ID: NCT00786994

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-11-30

Brief 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.

Detailed Description

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)

Group Type: EXPERIMENTAL

Oleogel-S10 100 mg/g

Intervention Type: DRUG

topical use once or twice daily

2

Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)

Group Type: EXPERIMENTAL

Oleogel-S10 100 mg/g

Intervention Type: DRUG

topical use once or twice daily

3

Placebo (petroleum jelly) for three months once a day (27 patients)

Group Type: PLACEBO_COMPARATOR

Placebo (petroleum jelly)

Intervention Type: DRUG

topical use once or twice daily

4

Placebo (petroleum jelly) for three months twice a day (27 patients)

Group Type: PLACEBO_COMPARATOR

Placebo (petroleum jelly)

Intervention Type: DRUG

topical use once or twice daily

Interventions

Oleogel-S10 100 mg/g

topical use once or twice daily

Intervention Type: DRUG

Placebo (petroleum jelly)

topical use once or twice daily

Intervention Type: DRUG

Other Intervention Names

Vaseline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Birken AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Garbe, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätshautklinik Tübingen

Locations

Charité University Hospital

Berlin, , Germany

University Dermatology Hospital

Freiburg im Breisgau, , Germany

University Dermatology Hospital

Tübingen, , Germany

Dermatology practice

Wuppertal, , Germany

National University, "Andreas Syggros" Skin & Venereal Diseases Hospital

Athens, , Greece

University Dermatology Hospital

Heraklion, , Greece

Countries

Germany; Greece

References

Pflugfelder A, Andonov E, Weide B, Dirschka T, Schempp C, Stockfleth E, Stratigos A, Kruger-Krasagakis S, Bauer J, Garbe C, Eigentler TK. Lack of activity of betulin-based Oleogel-S10 in the treatment of actinic keratoses: a randomized, multicentre, placebo-controlled double-blind phase II trial. Br J Dermatol. 2015 Apr;172(4):926-32. doi: 10.1111/bjd.13342. Epub 2015 Feb 25.

Reference Type: RESULT

PMID: 25124939 (View on PubMed)

Other Identifiers

BAK-08

Identifier Type: -

Identifier Source: org_study_id