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

Actinic Keratosis Clinical Trial

Official title:

Multicentre, Randomized, Parallel, Double-Blind, Vehicle Controlled Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In The Field-Directed Treatment Of Actinic Keratoses Grade I To II (Field Cancerization)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289768
• Other study ID #: 98605101-1401
• Secondary ID: 2014-001171-31AL
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2014
• Last updated: August 3, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• 5-fluorouracil/salicylic acid

• Vehicle

Locations

Country	Name	City	State
Germany	Almirall Investigational Site #3	Berlin
Germany	Almirall Investigational Site #4	Berlin
Germany	Almirall Investigational Site #5	Berlin
Germany	Almirall Investigational Site #1	Bochum
Germany	Almirall Investigational Site #8	Bochum
Germany	Almirall Investigational Site #6	Bonn
Germany	Almirall Investigational Site #9	Dülmen
Germany	Almirall Investigational Site #10	Friedrichshafen
Germany	Almirall Investigational Site #2	Selters
Germany	Almirall Investigational Site #7	Wuppertal
United Kingdom	Almirall Investigational Site #11	Leicester
United Kingdom	Almirall Investigational Site #12	Nantwich
United Kingdom	Almirall Investigational Site #13	Penzance
United Kingdom	Almirall Investigational Site #14	Penzance

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Almirall Hermal GmbH

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field	Complete Clinical Clearance is defined as no clinically visible actinic keratosis lesions in the selected treatment area	Week 20	No
Secondary	Percentage of patients with partial clinical clearance of actinic keratosis lesions in the treatment field	Partial clearance is defined as a 75% or greater reduction in the number of clinically visible actinic keratosis lesions in the selected treatment area	Week 20	No
Secondary	Percentage change from baseline in the total number of actinic keratosis lesions		Week 20	No
Secondary	Global assessment of efficacy by the physician (Physician Global Assessment)		Week 20	No
Secondary	Change from baseline in total score of the Dermatology Life Quality Index (DLQI)		Week 20	No
Secondary	Total score of the patients´ treatment satisfaction questionnaire for medication (TSQM)		Week 20	No
Secondary	Percentage of patients with complete clearance of three pre-defined subclinical actinic keratosis lesions	Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients	Week 20	No
Secondary	Percentage change from baseline in the three selected actinic keratosis subclinical lesions	Sub-clinical lesions will be determined using reflectance confocal microscopy in a subset of 30 patients	Week 20	No
Secondary	Percentage of patients for which the clearance of one pre-defined representative clinical actinic keratosis lesion is confirmed by reflectance confocal microscopy	Determined using reflectance confocal microscopy in a subset of 30 patients	Week 20	No
Secondary	The number of patients with adverse events		Week 20	Yes