NCT02289768

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_3

Geographic Reach
2 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 5, 2016

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

November 10, 2014

Last Update Submit

August 3, 2016

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Percentage of patients with partial clinical clearance of actinic keratosis lesions in the treatment field

    Week 20

  • Percentage change from baseline in the total number of actinic keratosis lesions

    Week 20

  • Global assessment of efficacy by the physician (Physician Global Assessment)

    Week 20

  • Change from baseline in total score of the Dermatology Life Quality Index (DLQI)

    Week 20

  • Total score of the patients´ treatment satisfaction questionnaire for medication (TSQM)

    Week 20

  • +4 more secondary outcomes

Study Arms (2)

5-fluorouracil/salicylic acid

EXPERIMENTAL

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

Drug: 5-fluorouracil/salicylic acid

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

5-fluorouracil/salicylic acidDRUG
Also known as: Actikerall
5-fluorouracil/salicylic acid
VehicleDRUG
Vehicle

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Almirall Investigational Site #3

Berlin, 10117, Germany

Location

Almirall Investigational Site #5

Berlin, 13055, Germany

Location

Almirall Investigational Site #4

Berlin, 13507, Germany

Location

Almirall Investigational Site #1

Bochum, 44791, Germany

Location

Almirall Investigational Site #8

Bochum, 44803, Germany

Location

Almirall Investigational Site #6

Bonn, 53111, Germany

Location

Almirall Investigational Site #9

Dülmen, 48249, Germany

Location

Almirall Investigational Site #10

Friedrichshafen, 88045, Germany

Location

Almirall Investigational Site #2

Selters, 56242, Germany

Location

Almirall Investigational Site #7

Wuppertal, 42275, Germany

Location

Almirall Investigational Site #11

Leicester, LE10 2SE, United Kingdom

Location

Almirall Investigational Site #12

Nantwich, CW5 5NX, United Kingdom

Location

Almirall Investigational Site #13

Penzance, TR18 4JH, United Kingdom

Location

Almirall Investigational Site #14

Penzance, TR19 7HX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 27995485DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

5-fluorouracil, salicylic acid drug combination

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wolf-Godehard Ocker

    Almirall Hermal GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 13, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

August 5, 2016

Record last verified: 2015-10

Locations

DE(10)GB(4)