actinic keratosis
Conditions
Interventions
Product Name: Solaraze
Product Code: 42752.00.00
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac
Current Sponsor code: NA
Other descriptive name: Diclofenac-Natrium
Concentration unit: % perc
Sponsors
Charité
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are willing and able to give written informed consent. 2. Are at least 18 years of age. 3. Have a minimum of 3 typical, visible and histologically proven Actinic Keratoses in the observation area (50 cm2) on one of the following regions: forehead, central face, scalp. 4. Patient is suffering from Actinic Keratoses with a minimum duration of 3 months 5. Are willing to eliminate tanning bed/sun parlor use during the study. 6. Are willing to stop using moisturizers and over-the-counter retinol products or products containing alpha or beta hydroxyacids in the observation area during the study. 7. Are willing and able to participate in the study as an outpatient, make frequent visits to the clinic, and comply with all study requirements, including the following: ? 3 clinic visits ? application of Solaraze® gel on observation area ? pretreatment biopsy for histological confirmation of AK-diagnosis and skin biopsy from univolved skin for laboratory (pathophysiological mechanisms) ? posttreatment biopsy for histological confirmation of AK-clearance or -persistence ? urine pregnancy testing for females of childbearing potential at treatment initiation 7. If female and of childbearing potential, subject is using a suitable form of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease. Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolaemia, or osteoarthritis will be allowed to enter the study. Have asthma or active gastrointestinal ulceration/bleeding. 2. Have any dermatological disease and or condition in the observation area or in the surrounding area (3cm distance from observation area) that may be exacerbated by treatment with Solaraze® gel or cause difficulty with examination (eg, rosacea, psoriasis, atopic dermatitis, eczema). 3. Are currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 4 weeks. 4. Have active chemical dependency or alcoholism, as assessed by the investigator. 5. Have known allergies to any of the ingredients of the study drug, i.e. allergy or hypersensitivity to aspirin or other NSAID 6. Pregnancy or lactating. 7. Have received any treatment at the observation area within a time period of 2 months. 8. Have invasive tumors within the observation area (eg., squamous cell carcinoma). Note: A biopsy of any lesion within the observation area suggestive of malignancy should be performed. If squamous cell carcinoma or other malignant conditions are confirmed within the observation area, the patient will not be included in the study. 9. Have received any cancer chemotherapy, or radiation therapy, within 6 months prior to study treatment initiation (patient must not have any evidence of systemic cancer). 10. Have received topically applied steroids within 4 weeks prior to treatment. 11. Have received the following systemic treatments within the designated period before study treatment initiation: Treatment Time Period Interferon 4 weeks Corticosteroids (oral or injectable) 4 weeks Inhaled corticosteroids (>1200 ?g/day for beclomethasone Or >600 ?g/day for fluticasone) 4 weeks Retinoids 4 weeks Investigational drugs 4 weeks Drugs known to have major organ toxicity 4 weeks Immunomodulators or immunosuppressive therapies 4 weeks 12. Have received ?15000 units per day of Vitamine A or derivates within 2 weeks prior to study treatment initiation. 13. Have used any topical preparations, such as over-the-counter retinol products, moisturizers, sunscreens or body oils, or alpha or beta hydroxyacids in the observation area within 24 hours prior to the visit. 14. Have used sunscreen in the observation area within a minimum of approximately 24 hours prior to study treatment initiation. 15. Have received Non steroidal anti-immflamatory drugs within 4 weeks prior to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the modulation of key factors involved in the pathophysiology of Actinic Keratosis by Solaraze. Comparison of levels of expression of the chosen factors between active treatment and no treatment. ;Secondary Objective: Efficacy will be measured by comparing target lesion number score (TLNS) and cumulative lesion number score (CLNS) at baseline to the end of study timepoint. Safety will be monitored throughout the study. ;Primary end point(s): Assessment of the modulation of key factors involved in the pathophysiology of Actinic Keratosis by Solaraze. Comparison of levels of expression of the chosen factors between active treatment and no treatment. | — |
Countries
Germany
Outcome results
None listed