The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Oleogel-S10 100 mg/g; Placebo (petroleum jelly)
Intervention description: topical use once or twice daily; topical use once or twice daily
Intervention MeSH terms: Petrolatum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratoses

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.
    

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.