Clinical trial NCT00786994: The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratoses
Keywords: Actinic Keratoses
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Tuebingen
First posted: 2008-11-06
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital
city: Freiburg
country: Germany
facility: University Dermatology Hospital
city: Tübingen
country: Germany
facility: University Dermatology Hospital
city: Wuppertal
country: Germany
facility: Dermatology practice
city: Athens
country: Greece
facility: National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
city: Heraklion
country: Greece
facility: University Dermatology Hospital
Study officials:
affiliation: Universitätshautklinik Tübingen
name: Claus Garbe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.