Actinic keratosis
Conditions
Interventions
Product Name: Solaraze® 3% Gel
Product Code: 42752.00.00
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac
Current Sponsor code: NA
Other descriptive name: Dicolfenac-Natrium
Concentration unit
Sponsors
Charité
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may participate in the study if they: 1. Are willing and able to give written informed consent. 2. Are at least 18 years of age. 3. Have a minimum of 5 Actinic Keratoses in the treatment area (50 cm2) on forehead, central face or scalp. 4. The Actinic Keratoses must be suitable for treatment with Solaraze, Efudix and Cryotherapy. 5. The Actinic Keratoses will be graded from low to moderate (°I and °II) 6. Patient is suffering from Actinic Keratoses with a minimum duration of 3 months 7. Are willing to eliminate tanning bed/sun parlor use during the study. 8. Are willing to stop using moisturizers and over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment area during the study. 9. 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: · 7 clinic visits during (screening, treatment, post-treatment, and follow-up period) · application of cream respectively ointment on treatment area · pretreatment biopsy for histological confirmation of AK-diagnosis and skin biopsy from univolved skin for laboratory (tumor markers) · 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 highly effective form of contraception. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used cinsistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 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: Patients will be excluded from the study if they: 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. 2. No patient with Actinic Keratoses with grading severe (°III) in the treatment area is allowed to participate in the study 3. Have any dermatological disease and or condition in the treatment that may be exacerbated by treatment with Solaraze, Efudix, Cryotherapy or cause difficulty with examination (eg, rosacea, psoriasis, atopic dermatitis, eczema). 4. Are currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 4 weeks. 5. Have active chemical dependency or alcoholism, as assessed by the investigator. 6. Have known allergies to any of the ingredients of the study drugs, i.e. allergy or hypersensitivity to acetylsalicylic acid or other NSAID 7. Pregnancy or lactating. 8. Have received any treatment at the treatment area within a time period of 2 months. 9. Have invasive tumors within the treatment area (eg., squamous cell carcinoma). Note: A biopsy of any lesion within the treatment area suggestive of malignancy should be performed at the prestudy screening visit. If squamous cell carcinoma or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study. 10. 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). 11. Have received topically applied steroids within 4 weeks prior to treatment. 12. Have received the following systemic treatments within 4 weeks before study treatment initiation: Interferon, Corticosteroids (oral or injectable), Inhaled corticosteroids (>1200 mg/day for beclomethasone or >600 mg/day for fluticasone), retinoids, investigational drug, drugs known to have major organ toxicity, immunomodulators or immunosuppressive therapies, NSAIDs 13. Have received >15000 units per day of Vitamine A or derivates within 2 weeks prior to study treatment initiation. 14. Have used any topical preparations, such as over-the-counter retinol products, moisturizers, sunscreens or body oils, or alpha or beta hydroxyacids in the treatment area within 24 hours prior to the all visit. 15. Have used sunscreen in the treatment area within a minimum of approximately 24 hours prior to study treatment initiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinically efficacy: (a) percent reduction of lesions after end-of-treatment in relation to individual baseline lesions; (b) recurrence rates of lesions after end-of-treatment and in follow-up period; (c) occurrence of new lesions after end-of-treatment and in follow-up period;Secondary Objective: 1. Assessment of oncogene staining before and after treatment 2. Safety assessment.;Primary end point(s): Clinically efficacy: (a) percent reduction of lesions after end-of-treatment in relation to individual baseline lesions; (b) recurrence rates of lesions after end-of-treatment and in follow-up period; (c) occurrence of new lesions after end-of-treatment and in follow-up period | — |
Countries
Germany
Outcome results
None listed