Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses

Almirall

Status and phase

Completed

Phase 3

Conditions

Actinic Keratosis

Treatments

Drug: Vehicle

Drug: 5-fluorouracil/salicylic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02289768

2014-001171-31 (EudraCT Number)

98605101-1401

ALM014 (Other Identifier)

Details and patient eligibility

About

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 treatment of grade I-II actinic keratosis, when it is applied to the affected area once daily for 12 weeks.

A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on subclinical actinic keratosis lesions in a subset of patients.

Enrollment

166 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.