IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis (Akti)
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ClinicalTrials.gov Identifier: NCT02281682 |
Recruitment Status : Unknown
Verified October 2017 by Maastricht University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : October 30, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratosis, Actinic | Drug: Imiquimod Drug: 5-fluorouracil Drug: Ingenol mebutate Procedure: methylaminolevulinate photodynamic therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 624 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | July 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Imiquimod
three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
|
Drug: 5-fluorouracil
during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
Other Name: Efudix Drug: Ingenol mebutate during 3 (consecutive) days once daily. Prior to treatment: curettage
Other Name: Picato Procedure: methylaminolevulinate photodynamic therapy methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
Other Name: MAL-PDT |
Active Comparator: 5-Fluorouracil
during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
|
Drug: Imiquimod
three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
Other Name: Aldara Drug: Ingenol mebutate during 3 (consecutive) days once daily. Prior to treatment: curettage
Other Name: Picato Procedure: methylaminolevulinate photodynamic therapy methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
Other Name: MAL-PDT |
Active Comparator: Ingenol mebutate 0.015%
during 3 (consecutive) days once daily. Prior to treatment: curettage
|
Drug: Imiquimod
three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
Other Name: Aldara Drug: 5-fluorouracil during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
Other Name: Efudix Procedure: methylaminolevulinate photodynamic therapy methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
Other Name: MAL-PDT |
Active Comparator: MAL-PDT
methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
|
Drug: Imiquimod
three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
Other Name: Aldara Drug: 5-fluorouracil during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
Other Name: Efudix Drug: Ingenol mebutate during 3 (consecutive) days once daily. Prior to treatment: curettage
Other Name: Picato |
- treatment succes [ Time Frame: 12 months ]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).
- treatment failure [ Time Frame: 12 months ]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).
- Treatment succes at 3 months post treatment [ Time Frame: 3 months ]proportion of participants with ≥75% reduction in number of AK lesions at 3 months post final treatment (≥ 75% patient clearance at 3 months).
- complete lesion clearance [ Time Frame: 12 months ]proportion of lesions with 100% clearance in all treated patients at 3 and 12 months post final treatment.
- SCC [ Time Frame: 12 months ]Proportion of patients who develop a SCC in the treatment area during study follow-up.
- side effects [ Time Frame: 12 months ]local skin reactions reported in patient diary, visual analogue score (VAS), Patient-reported adverse events
- Cosmetic outcome [ Time Frame: 3 and 12 months ]based on a Cosmetic questionnaire, filled in on baseline, 3 + 12 months
- patient satisfaction [ Time Frame: 12 months ]Skindex-29 questionnaire (quality of life) , Actinic Keratosis Quality of Life (AKQoL) questionnaire; filled in on baseline, 3 + 12 months
- treatment compliance [ Time Frame: 3 months ]defined as the number of applied treatments as percentage of the number of prescribed treatments, based on patient diaries and weighing returned medication.
- Overall decrease in AK [ Time Frame: 3 and 12 months ]Decrease in number AK from baseline per patient, at 3 and 12 months post final treatment.
- Cost-effectiveness [ Time Frame: 12 months ]Healthcare/treatment costs
- Investigator Global Improvement Indices [ Time Frame: 3 and 12 months ]Investigator Global Improvement Indices (IGII) at 3 and 12 months post final treatment.
- Number of new lesions [ Time Frame: 3 and 12 months ]Number of new lesions at 3 and 12 months post final treatment

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281682
Netherlands | |
Maastricht UMC | |
Maastricht, Limburg, Netherlands, 6202 AZ |
Principal Investigator: | Klara Mosterd, MD, PhD | Maastricht University Hospital |
Responsible Party: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT02281682 |
Other Study ID Numbers: |
NL50621.068.14 836031011 ( Other Grant/Funding Number: ZonMw ) 2014-003691-23 ( EudraCT Number ) |
First Posted: | November 2, 2014 Key Record Dates |
Last Update Posted: | October 30, 2017 |
Last Verified: | October 2017 |
Keratosis, Actinic Treatment Outcome cost-effectiveness economic evaluation |
imiquimod photodynamic therapy topical fluorouracil ingenol mebutate |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms Fluorouracil Imiquimod Methyl 5-aminolevulinate Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Interferon Inducers Photosensitizing Agents Dermatologic Agents |