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

NCT ID: NCT02281682

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

624 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Keratosis, Actinic

Keywords

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Keratosis, Actinic Treatment Outcome cost-effectiveness economic evaluation imiquimod photodynamic therapy topical fluorouracil ingenol mebutate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Imiquimod

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

Group Type ACTIVE_COMPARATOR

5-fluorouracil

Intervention Type DRUG

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

Ingenol mebutate

Intervention Type DRUG

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

methylaminolevulinate photodynamic therapy

Intervention Type PROCEDURE

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

5-Fluorouracil

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

Group Type ACTIVE_COMPARATOR

Imiquimod

Intervention Type DRUG

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

Ingenol mebutate

Intervention Type DRUG

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

methylaminolevulinate photodynamic therapy

Intervention Type PROCEDURE

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

Ingenol mebutate 0.015%

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

Group Type ACTIVE_COMPARATOR

Imiquimod

Intervention Type DRUG

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

5-fluorouracil

Intervention Type DRUG

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

methylaminolevulinate photodynamic therapy

Intervention Type PROCEDURE

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

MAL-PDT

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

Group Type ACTIVE_COMPARATOR

Imiquimod

Intervention Type DRUG

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

5-fluorouracil

Intervention Type DRUG

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

Ingenol mebutate

Intervention Type DRUG

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

Interventions

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Imiquimod

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

Intervention Type DRUG

5-fluorouracil

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

Intervention Type DRUG

Ingenol mebutate

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

Intervention Type DRUG

methylaminolevulinate photodynamic therapy

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

Intervention Type PROCEDURE

Other Intervention Names

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Aldara Efudix Picato MAL-PDT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klara Mosterd, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Locations

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Maastricht UMC

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 35475852 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33476658 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31961446 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30855743 (View on PubMed)

Other Identifiers

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836031011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2014-003691-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL50621.068.14

Identifier Type: -

Identifier Source: org_study_id