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Actinic KeratosesPhase 4NCT04875026

Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

A Phase 4 study testing 5-fluorouracil 4% (Tolak) and Dexeryl in people with Actinic Keratoses, run by Pierre Fabre Medicament at 27 sites in 4 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

Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Actinic Keratoses
What is being tested?
5-fluorouracil 4% (Tolak) and Dexeryl
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
27 sitesin 4 countries
Study dates
16 Feb 2021to 31 Jan 2022
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are eligible only if all of the following criteria apply:
  • Age
  • Participant must be more than 18 years old inclusive, at the time of signing the informed consent.
  • Type of Participant and Disease Characteristics
  • Individuals with a clinical diagnosis of actinic keratosis (AK).
  • Individuals harboring 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The AK lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
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  • Subject in good general condition and free of any disease state or condition which, in the investigator's opinion, could impair evaluation of actinic keratosis or could expose the subject to an unacceptable risk by study participation.
  • Sex
  • Male or female. A Female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP), defined as postmenopausal (cessation of menses >12 months) or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, total hysterectomy).
  • Informed Consent
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Ethical/Legal considerations
  • Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions
  • With AK lesions within treatment areas which are hyperkeratotic or which are clinically suspected to be squamous cell carcinoma (SCC).
  • With pre-existing local skin reactions with a total score ≥ 3.
  • History of hypersensitivity to the ingredients of Tolak® or Dexeryl®.
  • With a known allergy to peanut or soya.
Show all 21Show fewer
  • Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeeding women.
  • Prior/Concomitant Therapy
  • Under systemic 5-fluorouracil or any systemic cancer treatment within eight weeks prior to the study.
  • Under any other topical AK treatments or therapies (e.g., Cryotherapy or Photodynamic therapy) in the treatment area(s) within eight weeks prior to starting the study.
  • Treated with systemic steroids, immunosuppressants or immunomodulators within four weeks prior to the study.
  • Under prescription retinoids or topical steroids in the treatment area(s) within four weeks prior to the study.
  • With known dihydropyrimidinedehydrogénase (DPD) deficiency or under treatment with brivudine, sorivudine or analogues within 4 weeks prior to starting the study.
  • Treated with glycolic acid products and alpha-hydroxy products in the treatment area(s) within four weeks prior to starting the study.
  • Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study.
  • Prior/Concurrent Clinical Study Experience
  • Is participating in another clinical trial
  • Has participated in another clinical trial within the last 30 days, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial Other Exclusions
  • Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…)
  • Is in a position likely to represent a conflict of interest
  • Has forfeited his / her freedom by administrative or legal award or is under guardianship

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

Italy10 sites

  • Uni Clinic Brescia

    Brescia

  • Uni Clinic Catania

    Catania

  • Uni Clinic L'Aquila

    Coppito

  • Policlinico San Martino

    Genova

  • University of Messina

    Messina

  • Uni Clinic Modena

    Modena

  • NAPLES VANVITELLI UNIVERSITI (Federico II Hospital)

    Naples

  • Azienda Unità Sanitaria Locale - IRCCS

    Reggio Emilia

  • Catholic University Fondazione Policlinico Universitario A. Gemelli

    Roma

  • Sapienza University of Rome - Polo Pontino

    Terracina

Other trials in Italy

Germany7 sites

  • Kath. Klinikum Bochum St. Josef-Hospital

    Bochum

  • MVZ Dermatologisches Zentrum Bonn GmbH

    Bonn

  • Private practice Quist

    Bretzenheim

  • Private Practice Kurzen

    Freising

  • Dermatologikum Hamburg

    Hamburg

  • Hautarztpraxis

    Witten, 58453

  • CentroDerm Clinic

    Witten

Other trials in Germany

France5 sites

  • Private practice Maire

    Arras

  • Chu de Nantes Hôtel-Dieu

    Nantes

  • CHU Pau

    Pau

  • CHU Poitiers

    Poitiers

  • CHU St Etienne Hopital Nord

    Saint-Etienne

Other trials in France

Spain5 sites

  • Centre medic Congres

    Barcelona

  • Hospital Alfredo Espinosa

    Bilbao

  • Hospital Universitario Infanta Leonor

    Madrid

  • Instituto Valenciano de Oncología,

    Valencia

  • Hospital Marina Baixa

    Villajoyosa

Other trials in Spain

About this study

Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.

The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.

Being tested
5-fluorouracil 4% (Tolak), Dexeryl
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 4% (Tolak)Drug

    Application of Tolak once daily in the evening for 4 weeks

  • DexerylDevice

    Application of Dexeryl once daily in the morning for 8 weeks

Study groups in NCT04875026
Study groupRoleWhat they receive
5-fluorouracil 4% (Tolak) + DexerylExperimentalThis group will apply 5-FU once daily for 4 weeks, and Dexeryl once daily for 8 weeks.
Receives: Drug: 5-fluorouracil 4% (Tolak); Device: Dexeryl
5-fluorouracil 4% (Tolak)OtherThis group will only apply 5-FU once daily for 4 weeks.
Receives: Drug: 5-fluorouracil 4% (Tolak)

What is being measured

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

  1. Local Skin Reaction (LSR) total score

    Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).

    Measured: at 4 weeks or Last Observation Carried Forward (LOCF)

Secondary outcomes (29)

  1. Local Skin Reaction (LSR) total score

    Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).

    Measured: at 2 weeks (first follow-up)

  2. Local Skin Reaction (LSR) total score

    Investigator-assessed score: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) for a minimal score of 0 (best outcome possible), and a maximal score of 24 (worst outcome possible).

    Measured: at 8 weeks (last follow up)

  3. Local Skin Reaction (LSR) items alone

    Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst

    Measured: at 2 weeks (first follow-up)

  4. Local Skin Reaction (LSR) items alone

    Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst

    Measured: at 4 weeks (second follow up)

  5. Local Skin Reaction (LSR) items alone

    Presence/absence/intensity of each item of the LSR: 6 objective items scored from 0-4 (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration). For each item, 0 is the best outcome possible, 4 is the worst

    Measured: at 8 weeks (last follow up)

  6. Subjective signs at each visit

    Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.

    Measured: at 2 weeks (first follow-up)

  7. Subjective signs at each visit

    Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.

    Measured: at 4 weeks (second follow up)

  8. Subjective signs at each visit

    Patient questionnaire evaluating prurit (0-3), stinging/burning (0-3), pain (0-4). 0 is the best outcome, 10 is the worst outcome.

    Measured: at 8 weeks (last follow up)

  9. Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4

    Intensity grading of adverse events

    Measured: at 2 weeks (first follow-up)

  10. Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4

    Intensity grading of adverse events

    Measured: at 4 weeks (second follow up)

  11. Local reactions according to Common Terminology Criteria for Adverse Event (CTCAE) grade 3 or 4

    Intensity grading of adverse events

    Measured: at 8 weeks (last follow up)

  12. Adverse Events reported by patients or noticed by investigator

    Measured: at 2, 4 and 8 weeks (first follow-up)

  13. Drop outs due to Adverse Events (AE) related to local skin reaction

    discontinuation rate

    Measured: at 2, 4 and 8 weeks (first follow-up)

  14. Use of rescue treatment

    Measured: at 2 weeks (first follow-up)

  15. Use of rescue treatment

    Measured: at 4 weeks (second follow up)

  16. Use of rescue treatment

    Measured: at 8 weeks (last follow up)

  17. Treatment satisfaction (acceptability): measured by Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9)

    The TSQM-9 questionnaire includes nine questions that assess patients' satisfaction by providing score on three scales: effectiveness (questions 1 to 3), convenience (questions 4 to 6) and global satisfaction (questions 7 to 9). The scores of each scale range from 0 to 100, where a higher score indicates a greater satisfaction

    Measured: at 4 weeks (end of treatment) or at Patient Withdrawal

  18. Treatment adherence

    assessed by the participant using a self questionnaire

    Measured: at 4 weeks

  19. Treatment adherence

    assessed by the participant using a self questionnaire

    Measured: at optional visit (when applicable), up to 8 weeks

  20. Health-related quality of life measured by actinic keratosis quality of life questionnaire (AKQoL)

    actinic keratosis quality of life patient questionnaire, for Spain and Germany only. 0 is the best outcome, 27 is the worst outcome

    Measured: at 8 weeks (last follow up)

  21. Rates of patients with complete and partial clearance rates

    Measured: at 8 weeks (last follow up)

  22. Rates of patients with partial clearance rates

    Measured: at 8 weeks (last follow up)

  23. Percentage change in number of AK lesions

    Measured: at baseline

  24. Percentage change in number of AK lesions

    Measured: at 2 weeks (first follow-up)

  25. Change in number of AK lesions

    Measured: at 2 weeks (first follow-up)

  26. Percentage change in number of AK lesions

    Measured: at 4 weeks (second follow up)

  27. Change in number of AK lesions

    Measured: at 4 weeks (second follow up)

  28. Percentage change in number of AK lesions

    Measured: at 8 weeks (last follow up)

  29. Change in number of AK lesions

    Measured: at 8 weeks (last follow up)

Timeline

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

  1. First posted6 May 2021
  2. Study start16 Feb 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875026
Sponsor's protocol ID
W00118 CR 401
Other IDs
2020-000851-11
Status last verified
Sep 2022
First submitted
18 Mar 2021
Last updated
19 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 5-fluorouracil 4% (Tolak) and Dexeryl in people with Actinic Keratoses, run by Pierre Fabre Medicament at 27 sites in 4 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 13 inclusion and 21 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 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy, Germany, France, Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Local Skin Reaction (LSR) total score (time frame: at 4 weeks or Last Observation Carried Forward (LOCF)). 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 NCT04875026.

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 19 Sep 2022.

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