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…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: treatment success, i.e. 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).
Secondary outcome
- 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).
- Treatment success 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).
- Decrease in number AK from baseline per patient, at 3 and 12 months post
final treatment.
- Complete lesion clearance: proportion of lesions with 100% clearance in all
treated patients at 3 and 12 months post final treatment.
- Investigator Global Improvement Indices (IGII) at 3 and 12 months post final
treatment.
- Number of new lesions at 3 and 12 months post final treatment.
- Healthcare/treatment costs
- Side effects
- Patient satisfaction
- Cosmetic outcome
- Treatment compliance, defined as the number of applied treatments as
percentage of the number of prescribed treatments.
- Proportion of patients who develop a SCC in the treatment area during study
follow-up and long-term follow-up.
Background summary
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 is to
investigate what is the most effective field-directed treatment for AK
Study objective
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)
Study design
Multi-centre randomised controled single blind clinical phase IV trial
Intervention
5% Imiquimod versus 5% 5-fluorouracil versus Ingenol mebutate versus
MAL-photodynamic therapy
Study burden and risks
During and post treatment patients will be asked to answer a short
questionnaire regarding side effects, experience of the treatment and
satisfaction. For the long-term follow-up, one extra visit is necessary.
P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25 P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Patients older than 18 years
- Female in child bearing potential should be using contraceptive
measures, during and till 3
months post-treatment
- 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 within the joint area
- AK Olsen grade I-III
- Location: head/neck area
Exclusion criteria
- Received any kind of treatment for AK in the past 3 months, except for
cryosurgery outside the treatment area.
- (N)MSC in target area
- Immuno-comprised status
- Use of immunosuppressant drugs in the past 3 months and / or at time of
treatment (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
- Genetic skin cancer disorders
- No understanding of dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003691-23-NL |
| CCMO | NL50621.068.14 |
| OMON | NL-OMON22756 |