ACTINIC KERATOSES GRADE I TO II (FIELD CANCERIZATION) MedDRA version: 17.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Actikerall 5 mg/g + 100 mg/g Lösung zur Anwendung auf der Haut
Product Name: Actikerall
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: FLUOROURACIL
CAS Number: 51218
Other d
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or non-pregnant, non-lactating (in the last 3 months) female aged between 18 and 85 years (both inclusive). Women of childbearing potential will follow specific study requirements. 2. Patients with at least 4 but not more than 10 clinically confirmed AK lesions grade I or II according to Olsen EA et al. 1991 within a field of cancerization of 25 cm² in the face/forehead or bald scalp 3. Patients with skin type I to IV according to Fitzpatrick 4. Patients free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may interfere with area examination or final evaluation. 5. Patients in good health condition or free of medical conditions that may interfere with the study results as confirmed by a physical examination, medical history and laboratory analysis. 6. Patients who accept to refrain from sunbathing, intense UV-light exposure and the solarium during the study duration. 7. Patients willing to stop using moisturizers and topical treatments with anti-aging products, vitamins A, C, and/or E containing ointments and gels and green tea preparations in the treatment area. 8. Patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions Additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study: 9. Patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions. 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 97 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: 1. Subjects that have received treatment for AK within the treatment area in the 3 months previous to Visit 1 (screening). 2. Subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than AK within the treatment area before randomization (Visit 2). 3. Subjects that have received prohibited systemic treatments for any indication before randomization (Visit 2). 4. Subjects taking phenytoin, methotrexate or sulfonylurea. 5. Subjects with dermatological diseases in the treatment area or surrounding area that may be exacerbated by the study treatment or may interfere the study assessments (e.g. psoriasis, eczema). 6. Subjects that have currently malignant or benign tumors of the skin within the treatment area (e.g., malignant melanoma, basal cell carcinoma, squamous cell carcinoma). 7. Subjects that suffer from any kind of photodermatoses 8. Subjects that have evidence of clinically significant unstable medical conditions. 9. Subjects with known hypersensitivity to any of the trial drugs (5-fluorouracil, salicylic acid), to ingredients of the trial formulation, or to drugs of similar chemical classes 10. Subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate 11. Subjects with dihydropyrimidine dehydrogenase deficiency (DPD deficiency). 12. Subjects that are currently participating or have participated within the 8 weeks prior to Visit 1 in another clinical trial. 13. Patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to Visit 1. 14. Subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the efficacy and safety of Actikerall® solution in the field-directed treatment of actinic keratosis grade I to II (field cancerization) ;Secondary Objective: to evaluate the efficacy of Actikerall® solution on subclinical actinic keratosis lesions using reflectance confocal microscopy (RCM) in a subset of patients ;Primary end point(s): Percentage of patients with complete clinical clearance (CCC) of AK lesions in the treatment field at 8 weeks post last treatment ;Timepoint(s) of evaluation of this end point: 8 weeks post last treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After 2, 4, 6, 8 and 12 weeks of treatment and week 8 post last treatment.;Secondary end point(s): 1. Percentage of patients with complete clinical clearance (CCC) of AK lesions in the treatment field at each treatment visit (after 2, 4, 6 and 12 weeks of treatment). 2. Percentage of patients with partial clearance of AK lesions in the treatment field at each treatment visit (after 2, 4, 6 and 12 weeks of treatment) and at week 8 post last treatment. 3. Percentage change from baseline in the total number of AK lesion count at each treatment visit and at week 8 post last treatment. 4. Number of lesions by AK grade severity according to Olsen et al. (0, I, II or III) at baseline and at week 8 post-treatment. 5. Percentage change from baseline in the total number of AK lesions (patient level) at each treatment visit and at week 8 post last treatment. 6. Global assessment of efficacy by the physician (PGA, Physician Global Assessment) at each treatment visit (after 2, 4, 6 and 12 weeks of treatment) and at week 8 post last treatment. 7. Change from baseline in total score and individual domains of the Dermatology Life Quality Index (DLQI) after 12 weeks of treatment and at week 8 post last treatment. 8. Total score and individual domains of the patients´ treatment satisfaction questionnaire for medication (TSQM) at week 8 post last treatment. In a subset of 30 patients: 9. Percentage of patients with complete clearance of the 3 selected sub-clinical actinic keratosis lesions in the 25 cm² treatment field assessed by systematic RCM imaging of the treatment field after 4 weeks of treatment, 6 weeks of treatment, after 12 weeks of treatment and 8 weeks post last treatment. 10. Percentage change from baseline in the 3 selected sub-clinical actinic keratosis lesions count after 4 weeks of treatment, after 6 weeks of treatment, after 12 weeks of treatment and 8 weeks post last treatment. 11. Percentage of patients for which | — |
Countries
Germany, United Kingdom
Contacts
Public ContactFurther Information on the trial
SCIderm GmbH
Outcome results
None listed