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

NCT ID: NCT02289768

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-30

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 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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

5-fluorouracil/salicylic acid

Actikerall® solution (5-fluorouracil 0.5%, salicylic acid 10.0%) applied to the affected area once-daily for 12 weeks

Group Type: EXPERIMENTAL

5-fluorouracil/salicylic acid

Intervention Type: DRUG

Vehicle

Vehicle solution applied to the affected area once-daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Interventions

5-fluorouracil/salicylic acid

Intervention Type: DRUG

Vehicle

Intervention Type: DRUG

Other Intervention Names

Actikerall

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall Hermal GmbH

INDUSTRY

Sponsor Role: collaborator

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolf-Godehard Ocker

Role: STUDY_DIRECTOR

Almirall Hermal GmbH

Locations

Almirall Investigational Site #3

Berlin, , Germany

Almirall Investigational Site #5

Berlin, , Germany

Almirall Investigational Site #4

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, , Germany

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, , United Kingdom

Countries

Germany; United Kingdom

References

Stockfleth E, von Kiedrowski R, Dominicus R, Ryan J, Ellery A, Falques M, Ivanoff N, Azeredo RR. Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10% in the Field-Directed Treatment of Actinic Keratosis: A Phase III, Randomized, Double-Blind, Vehicle-Controlled Trial. Dermatol Ther (Heidelb). 2017 Mar;7(1):81-96. doi: 10.1007/s13555-016-0161-2. Epub 2016 Dec 19.

Reference Type: DERIVED

PMID: 27995485 (View on PubMed)

Other Identifiers

2014-001171-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALM014

Identifier Type: OTHER

Identifier Source: secondary_id

98605101-1401

Identifier Type: -

Identifier Source: org_study_id