E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
1. Assessment of oncogene staining before and after treatment 2. Safety assessment. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Spray-Cryotherapy with liquid nitrogen |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Start: 1st of July 2006 (inclusion of last pt. 6 month after start) Inclusion period: 1st of July 2006 – 31st of December 2006 Treatment period: max. 3 months End of Phase I (treatment period): 30th of April 2007 End of Phase II (folllow up period): 30th of April 2008 Final report: June 2008 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |