Clinical Trial Results:
PpIX in curetted and non-curetted skin after Metvix application
Summary
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EudraCT number |
2016-005084-14 |
Trial protocol |
DK |
Global end of trial date |
31 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2020
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First version publication date |
04 Jun 2020
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Other versions |
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 |
56297
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bispebjerg Hospital
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Sponsor organisation address |
Bispebjerg Bakke 23, Copenhagen NV, Denmark,
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Public contact |
Department of Dermatology, D92, Bispbjerg hospital , hans.christian.olsen.wulf@regionh.dk
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Scientific contact |
Department of Dermatology, D92, Bispbjerg hospital , hans.christian.olsen.wulf@regionh.dk
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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 |
01 Dec 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 May 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
31 May 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To investigate how fast PpIX is produced in curetted and non-curetted skin.
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Protection of trial subjects |
Not necessary
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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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 |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
Subjects were recruited from the Department of Dermatology, Bispebjerg Hospital | |||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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+cur | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Metvix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Cutaneus use
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Arm title
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-cur | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Metvix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Cutaneus use
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
+cur
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Reporting group description |
- | ||
Reporting group title |
-cur
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Reporting group description |
- |
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End point title |
PpIX level | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
PpIX level 3 h after MAL application
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Statistical analysis title |
Wilcoxon Signed Ranks Test | |||||||||
Statistical analysis description |
Parred design. Only 14 subjects in this analysis.
Read all about the analysis here:
Heerfordt IM, Bieliauskiene G, Wulf HC. Protoporphyrin IX formationafter application of methyl aminolevulinate on the face and scalp withand without prior curettage. Photodiagnosis Photodyn Ther 2018; 22: 155–157
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Comparison groups |
-cur v +cur
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [1] | |||||||||
P-value |
= 0.9 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Notes [1] - Parred design. Only 14 subjects in this analysis. Read all about the analysis here: Heerfordt IM, Bieliauskiene G, Wulf HC. Protoporphyrin IX formationafter application of methyl aminolevulinate on the face and scalp withand without prior curettage. Photodiagnosis Photodyn Ther 2018; 22: 155–157 |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From MAL application and 6 h ahead
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
+cur
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Reporting group description |
- | |||||||||||||||
Reporting group title |
-cur
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Reporting group description |
- | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-serious adverse events. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |