Status:
COMPLETED
Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses
Lead Sponsor:
Almirall, S.A.
Collaborating Sponsors:
Almirall Hermal GmbH
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The main purpose of this vehicle-controlled study is to determine the efficacy and safety of a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the field-directed t...
Eligibility Criteria
Inclusion
- 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.
- Patients with at least 4 but not more than 10 clinically confirmed actinic keratoses 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.
- Patients with skin type I to IV (according to Fitzpatrick Skin Types)
- 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.
- 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.
- Patients who accept to refrain from sunbathing, intense UV-light exposure and the solarium during the study duration.
- 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.
- Patients able (physical ability or supportive person) to apply the study preparations correctly and to follow the study procedure and restrictions.
- Patients with at least 3 subclinical lesions in the 25 cm² test area (field) clearly separated from each other and the actinic keratoses lesions (additional inclusion criteria for the patients participating on the sub-clinical lesions sub-study).
Exclusion
- Subjects that have received treatment for actinic keratoses within the treatment area in the 3 months previous to Visit 1 (screening).
- Subjects that have received prohibited pharmacological or non-pharmacological treatments for any indication other than actinic keratoses within the treatment area before randomization (Visit 2).
- Subjects that have received prohibited systemic treatments for any indication before randomization (Visit 2).
- Subjects taking phenytoin, methotrexate or sulfonylurea.
- 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).
- 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).
- Subjects that suffer from any kind of photodermatoses.
- Subjects that have evidence of clinically significant unstable medical conditions.
- 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
- Subjects with allergy against dimethylsulfoxide, ethanol, ethyl acetate, pyroxyline, poly(butyl)methacrylate, and/or methylmethacrylate.
- Subjects with dihydropyrimidine dehydrogenase deficiency (DPD deficiency).
- Subjects that are currently participating or have participated within the 8 weeks prior to Visit 1 in another clinical trial.
- Patients with known drug or alcohol abuse as assessed by the investigator within the 2 years prior to Visit 1.
- Subject is institutionalized because of legal or regulatory order.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT02289768
Start Date
October 1 2014
End Date
September 1 2015
Last Update
August 5 2016
Active Locations (14)
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1
Almirall Investigational Site #3
Berlin, Germany, 10117
2
Almirall Investigational Site #5
Berlin, Germany, 13055
3
Almirall Investigational Site #4
Berlin, Germany, 13507
4
Almirall Investigational Site #1
Bochum, Germany, 44791