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Keratosis, ActinicPhase 4AktiNCT02281682

IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis

A Phase 4 study testing Imiquimod, 5-fluorouracil and Ingenol mebutate in people with Keratosis, Actinic, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Keratosis, Actinic
What is being tested?
Imiquimod, 5-fluorouracil and Ingenol mebutate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
624 participants
Where
1 siteNetherlands
Study dates
Nov 2014to Dec 2018
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

  • Patients older than 18 years
  • Fitzpatrick skintype I-IV
  • Clinically confirmed diagnosis of AK
  • One joint area of minimal 25 cm2 and maximal 100 cm2 of AK
  • Minimum of 5 AK lesions
  • AK Olsen grade I-III
  • Location: head/neck area

Who cannot join

  • Received any kind of treatment for AK in the past 3 months
  • (non)melanoma skin cancer in target area
  • Immuno-compromised status
  • Use of systemic retinoid in the past 3 months
  • Use of immunosuppressant drugs in the past 3 months and / or at time of treatment (such as oral glucocorticoids, cytostatic, antibodies, drug acting on immunophilins, interferon, opioids, Tumor Necrosis Factor (TNF) binding proteins, mycofenolate mofetil (MMF), biologic agents). inhalation corticosteroids / nasal corticosteroids are permitted.
  • Porphyria
Show all 12Show fewer
  • Not able to give informed consent
  • Allergy to study drugs or peanut/nut/soy products
  • Pregnant and breastfeeding women
  • Female in child bearing potential not using contraceptive measures, during and till 3 months post-treatment
  • Genetic skin cancer disorders
  • Not understanding Dutch language

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht UMC

    Maastricht, Limburg, 6202 AZ

Other trials in Netherlands

About this study

Official title: Topical Ingenol Mebutate Versus 5% 5-fluorouracil Versus 5% Imiquimod Versus Photodynamic Therapy in Treatment of Actinic Keratosis: a Multi-centre Randomized Efficacy and Cost-effectiveness Study

A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel.

Read the detailed description

Skin cancer is the most common cancer in Caucasians and therefore a major public health issue. Its incidence is increasing rapidly. Actinic keratosis (AK) is the most prevalent precancerous chronic skin condition. It can transform into squamous cell carcinoma (SCC). AK's generally arise in a skin area that has diffuse precancerous damage, a phenomenon called field cancerization. Because of its precancerous character, it is advised to treat AK and herewith prevent development into SCC. The most frequently used field-directed treatments in the Netherlands are photodynamic therapy (PDT), topical 5% f-fluorouracil (5% 5-FU) and topical 5% Imiquimod (5% IMI). Lately another topical product is approved by Dutch healthcare insurances: Ingenol mebutate (IM). Up to date, which treatment the patient will receive, does not rely on evidence-based-medicine, but generally on the preference of the physician. Current national and international guidelines state no clear recommendations for the best choice of therapy. The aim of this study determine which treatment is the most effective treatment in terms of lesion reduction, costs and patient satisfaction when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel, in treatment of actinic keratosis (AK).

Being tested
Imiquimod, 5-fluorouracil, Ingenol mebutate, methylaminolevulinate photodynamic therapy
Keywords
Keratosis, Actinic, Treatment Outcome, cost-effectiveness, economic evaluation, imiquimod, photodynamic therapy, topical fluorouracil, ingenol mebutate
Medical subject headings
Keratosis, Actinic

What participants receive

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

  • ImiquimodDrug

    Also called Aldara

    three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage

  • 5-fluorouracilDrug

    Also called Efudix

    during 4 (consecutive) weeks twice daily. Prior to treatment: curettage

  • Ingenol mebutateDrug

    Also called Picato

    during 3 (consecutive) days once daily. Prior to treatment: curettage

  • methylaminolevulinate photodynamic therapyProcedure or surgery

    Also called MAL-PDT

    methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage

Study groups in NCT02281682
Study groupRoleWhat they receive
ImiquimodActive comparatorthree times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
Receives: Drug: 5-fluorouracil; Drug: Ingenol mebutate; Procedure: methylaminolevulinate photodynamic therapy
5-FluorouracilActive comparatorduring 4 (consecutive) weeks twice daily. Prior to treatment: curettage
Receives: Drug: Imiquimod; Drug: Ingenol mebutate; Procedure: methylaminolevulinate photodynamic therapy
Ingenol mebutate 0.015%Active comparatorduring 3 (consecutive) days once daily. Prior to treatment: curettage
Receives: Drug: Imiquimod; Drug: 5-fluorouracil; Procedure: methylaminolevulinate photodynamic therapy
MAL-PDTActive comparatormethylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
Receives: Drug: Imiquimod; Drug: 5-fluorouracil; Drug: Ingenol mebutate

What is being measured

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

  1. treatment succes

    the proportion of patients with ≥75% lesion reduction in the number of AK lesions counted at baseline in the treatment area 12 months post final treatment (≥ 75% patient clearance at 12 months).

    Measured: 12 months

Secondary outcomes (12)

  1. treatment failure

    proportion of participants with <75% reduction in number of AK lesions after 3 and 12 months post final treatment compared to baseline (<75% patient clearance at 3 and 12 months).

    Measured: 12 months

  2. Treatment succes at 3 months post treatment

    proportion of participants with ≥75% reduction in number of AK lesions at 3 months post final treatment (≥ 75% patient clearance at 3 months).

    Measured: 3 months

  3. complete lesion clearance

    proportion of lesions with 100% clearance in all treated patients at 3 and 12 months post final treatment.

    Measured: 12 months

  4. SCC

    Proportion of patients who develop a SCC in the treatment area during study follow-up.

    Measured: 12 months

  5. side effects

    local skin reactions reported in patient diary, visual analogue score (VAS), Patient-reported adverse events

    Measured: 12 months

  6. Cosmetic outcome

    based on a Cosmetic questionnaire, filled in on baseline, 3 + 12 months

    Measured: 3 and 12 months

  7. patient satisfaction

    Skindex-29 questionnaire (quality of life) , Actinic Keratosis Quality of Life (AKQoL) questionnaire; filled in on baseline, 3 + 12 months

    Measured: 12 months

  8. treatment compliance

    defined as the number of applied treatments as percentage of the number of prescribed treatments, based on patient diaries and weighing returned medication.

    Measured: 3 months

  9. Overall decrease in AK

    Decrease in number AK from baseline per patient, at 3 and 12 months post final treatment.

    Measured: 3 and 12 months

  10. Cost-effectiveness

    Healthcare/treatment costs

    Measured: 12 months

  11. Investigator Global Improvement Indices

    Investigator Global Improvement Indices (IGII) at 3 and 12 months post final treatment.

    Measured: 3 and 12 months

  12. Number of new lesions

    Number of new lesions at 3 and 12 months post final treatment

    Measured: 3 and 12 months

Timeline

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

  1. First posted3 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJul 2018 (estimated)
  4. Study completionDec 2018 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281682
Sponsor's protocol ID
NL50621.068.14
Other IDs
836031011, 2014-003691-23, 2014
Acronym
Akti
Status last verified
Oct 2017
First submitted
28 Oct 2014
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034.

    PubMed 35475852

  • Ahmady S, Jansen MHE, Nelemans PJ, Essers BAB, Kessels JPHM, Kelleners-Smeets NWJ, Mosterd K. The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL. J Invest Dermatol. 2021 Jul;141(7):1830-1832. doi: 10.1016/j.jid.2020.12.023. Epub 2021 Jan 18. No abstract available.

    PubMed 33476658

  • Jansen MHE, Kessels JPHM, Merks I, Nelemans PJ, Kelleners-Smeets NWJ, Mosterd K, Essers BAB. A trial-based cost-effectiveness analysis of topical 5-fluorouracil vs. imiquimod vs. ingenol mebutate vs. methyl aminolaevulinate conventional photodynamic therapy for the treatment of actinic keratosis in the head and neck area performed in the Netherlands. Br J Dermatol. 2020 Oct;183(4):738-744. doi: 10.1111/bjd.18884. Epub 2020 Feb 19.

    PubMed 31961446

  • Jansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056/NEJMoa1811850.

    PubMed 30855743

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imiquimod, 5-fluorouracil and Ingenol mebutate in people with Keratosis, Actinic, run by Maastricht University Medical Center at 1 site in Netherlands.

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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

Results are not available in the source record.

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?

treatment succes (time frame: 12 months). 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 NCT02281682, which also lists 4 linked publications.

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 30 Oct 2017.

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