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Actinic KeratosisPhase 3NCT02289768

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

A Phase 3 study testing 5-fluorouracil/salicylic acid in people with Actinic Keratosis, run by Almirall, S.A. at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Actinic Keratosis
What is being tested?
5-fluorouracil/salicylic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
14 sitesin 2 countries
Study dates
Oct 2014to Sep 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Germany10 sites

  • Almirall Investigational Site #3

    Berlin, 10117

  • Almirall Investigational Site #5

    Berlin, 13055

  • Almirall Investigational Site #4

    Berlin, 13507

  • Almirall Investigational Site #1

    Bochum, 44791

  • Almirall Investigational Site #8

    Bochum, 44803

  • Almirall Investigational Site #6

    Bonn, 53111

  • Almirall Investigational Site #9

    Dülmen, 48249

  • Almirall Investigational Site #10

    Friedrichshafen, 88045

  • Almirall Investigational Site #2

    Selters, 56242

  • Almirall Investigational Site #7

    Wuppertal, 42275

Other trials in Germany

United Kingdom4 sites

  • Almirall Investigational Site #11

    Leicester, LE10 2SE

  • Almirall Investigational Site #12

    Nantwich, CW5 5NX

  • Almirall Investigational Site #13

    Penzance, TR18 4JH

  • Almirall Investigational Site #14

    Penzance, TR19 7HX

Other trials in United Kingdom

About this study

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)

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.

Being tested
5-fluorouracil/salicylic acid, Vehicle
Medical subject headings
Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-fluorouracil/salicylic acidDrug

    Also called Actikerall

  • VehicleDrug

Study groups in NCT02289768
Study groupRoleWhat they receive
5-fluorouracil/salicylic acidExperimentalActikerall® solution (5-fluorouracil 0.5%, salicylic acid 10.0%) applied to the affected area once-daily for 12 weeks
Receives: Drug: 5-fluorouracil/salicylic acid
VehiclePlacebo comparatorVehicle solution applied to the affected area once-daily for 12 weeks
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 20

Secondary outcomes (9)

  1. 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

    Measured: Week 20

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

    Measured: Week 20

  3. Global assessment of efficacy by the physician (Physician Global Assessment)

    Measured: Week 20

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

    Measured: Week 20

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

    Measured: Week 20

  6. 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

    Measured: Week 20

  7. 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

    Measured: Week 20

  8. 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

    Measured: Week 20

  9. The number of patients with adverse events

    Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02289768
Sponsor's protocol ID
98605101-1401
Other IDs
2014-001171-31, ALM014, 2014
Status last verified
Oct 2015
First submitted
10 Nov 2014
Last updated
5 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27995485

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-fluorouracil/salicylic acid in people with Actinic Keratosis, run by Almirall, S.A. at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with complete clinical clearance of actinic keratosis lesions in the treatment field (time frame: Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02289768, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.

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