Clinical Trial Results:
RANDOMISED PILOT STUDY TO ASSESS THE CLINICAL EFFICACY OF DAYLIGHT PHOTODYNAMIC THERAPY WITH METHYL AMINOLEVULINATE CREAM (METVIX?), (MAL-PDT), IN THE PREVENTION OF ACTINIC KERATOSIS AND NON MELANOMA SKIN CANCER IN TRANSPLANT PATIENTS
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Summary
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EudraCT number |
2015-002663-42 |
Trial protocol |
ES |
Global end of trial date |
25 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Oct 2021
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First version publication date |
20 Oct 2021
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Other versions |
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Summary report(s) |
Final report summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TFDTRASP
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Clínica Universidad de Navarra
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Sponsor organisation address |
Avda. Pío XII, 36, Pamplona, Spain, 31008
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Public contact |
UCEC, Clínica Universidad de Navarra, 34 9482554002725, ucicec@unav.es
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Scientific contact |
UCEC, Clínica Universidad de Navarra, 34 9482554002725, ucicec@unav.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Sep 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Oct 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Oct 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Assess if there are less appearance of AK in the side treated with repeated treatments of daylight photodynamic therapy compared with the side treated with cryotherapy, in transplant patients, at 21 months from treatment initiation.
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Mar 2016
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
21 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
20
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 24 patients were included. Three patients were lost. One after the first intervention and two after the 3-month visit. All treatment and follow-up visits were completed by 21 patients. All patients were male and Caucasian. | ||||||||||
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Pre-assignment
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Screening details |
Recruitment started in April 2016 and ended in February 2017. 25 patients were selected, of which 24 were included. One patient was not finally included because he did not meet the inclusion criteria. | ||||||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
Blind for evaluator and not blind for the patient and the doctor.
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Arms
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Arm title
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Treatment | ||||||||||
Arm description |
This study has an intra-individual comparison design, in which a half-face was treated with MAL-PDT in daylight and the contralateral side was the control in each patient. The control side was treated with cryotherapy, which is the best treatment option for now, and is what is commonly used to treat actinic keratoses in these types of patients. This design, therefore, is not a crossover design since each treatment was applied to a different area at the same time. It is a design commonly used in dermatology for the comparison of topical treatments. The sides of the face and / or the scalp were randomly assigned to the interventions based on a computer generated sequence. Each patient was assigned an order number. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
metil-aminolevulinato (MAL) in combination with Photodynamic therapy (PDT)
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Investigational medicinal product code |
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Other name |
Metvix
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
1st Treatment at most 3 weeks after inclusion: TFD-MAL with daylight of a half face and Cryotherapy (2 freezing cycles) on the contralateral side on the day of initiation of treatment.
2nd Treatment carried out 3 months after the first treatment: TFD-MAL with daylight of a half face and Cryotherapy (2 freezing cycles) on the contralateral side on the day of initiation of treatment.
3rd Treatment: carried out 9 months after the first treatment: TFD-MAL with daylight of a half face and Cryotherapy (2 freezing cycles) on the contralateral side on the day of initiation of treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
This study has an intra-individual comparison design, in which a half-face was treated with MAL-PDT in daylight and the contralateral side was the control in each patient. The control side was treated with cryotherapy, which is the best treatment option for now, and is what is commonly used to treat actinic keratoses in these types of patients. This design, therefore, is not a crossover design since each treatment was applied to a different area at the same time. It is a design commonly used in dermatology for the comparison of topical treatments. The sides of the face and / or the scalp were randomly assigned to the interventions based on a computer generated sequence. Each patient was assigned an order number. | ||
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End point title |
Difference in the number of total lesions between the two treatment areas at the final visit [1] | ||||||
End point description |
Difference in the number of total lesions between the two treatment areas at the final visit, V21, observed in the physical examination performed at that visit, compared to the pretreatment physical examination.
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End point type |
Primary
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End point timeframe |
21 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses have been specified for this primary end point because there is only one group treatment and the end point is meassure of the difetrence number of lessions before and after the clinical trial. All the variables were analyzed using the Student's t test for paired data or the Wilcoxon test of signed ranges for paired data. The cut-off point for establishing statistical significance was 0.05. All analyzes were performed using Stata 14 (StataCorp. 2015). |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
21 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
NA
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Reporting groups
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Reporting group title |
Treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Sep 2016 |
modificate some aspects about the recruitmen, inclusion criteria and withdrawal |
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16 Jan 2018 |
Include a partial statistical analysis |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
