Vehicle controlled study to evaluate the efficacy and safety of Actikerall® solution in the field-directed treatment of actinic keratoses grade I to II

Conditions: ACTINIC KERATOSES GRADE I TO II (FIELD CANCERIZATION)
MedDRA version: 17.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-001171-31-DE

Lead Sponsor: Almirall Hermal GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 162

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method

Related Trials