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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Oleogel-S10 100 mg/g
* Drug: Placebo (petroleum jelly)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oleogel-S10 100 mg/g ointment for three months once a day (54 patients) | Drug: Oleogel-S10 100 mg/g<br>* topical use once or twice daily<br>|
| Experimental: 2<br>Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients) | Drug: Oleogel-S10 100 mg/g<br>* topical use once or twice daily<br>|
| Placebo Comparator: 3<br>Placebo (petroleum jelly) for three months once a day (27 patients) | Drug: Placebo (petroleum jelly)<br>* topical use once or twice daily<br>* Other names: Vaseline;|
| Placebo Comparator: 4<br>Placebo (petroleum jelly) for three months twice a day (27 patients) | Drug: Placebo (petroleum jelly)<br>* topical use once or twice daily<br>* Other names: Vaseline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance. | Objective response of the marker actinic keratosis, defined as histologically 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. The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success. | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratoses