Clinical Trial Results:
Calcipotriol zur Prävention der Polymorphen Lichtdermatose
Summary
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EudraCT number |
2008-000626-39 |
Trial protocol |
AT |
Global end of trial date |
14 Oct 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Oct 2019
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First version publication date |
17 Oct 2019
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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 |
Calcipotriol_PLD_1.0
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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 |
Medical University of Graz
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Sponsor organisation address |
Auenbruggerplatz 8, Graz, Austria, 8036
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Public contact |
Clinical Trial information, Medical University of Graz, peter.wolf@medunigraz.at
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Scientific contact |
Clinical Trial information, Medical University of Graz, peter.wolf@medunigraz.at
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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 |
11 Feb 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 May 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Oct 2010
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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 |
To investigate the efficacy of a pretreatment with calcipotriol in polymorphic light eruption.
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Protection of trial subjects |
The study was approved by the local Ethics Committee and was conducted according to the principles of Good Clinical Practice.
Patients were subjected to Standard photo testing, as applied in daily Routine practice.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2009
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Long term follow-up planned |
No
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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 |
Austria: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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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) |
12
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment started in February 2009 and was terminated in May 2009. | ||||||
Pre-assignment
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Screening details |
26 patients were pre-screened. 15 patients provided Informed Consent. Of these, 13 patients were subjected to Treatment (half-side Treatment). | ||||||
Period 1
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Period 1 title |
Overall trial (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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Arm title
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Half-side treatment | ||||||
Arm description |
13 Patients were treated with Calcipotriol on one body side and Placebo on the other Body site. The intra- individual Body site to be treated was determined by randomization. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Calcipotriol
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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 |
Calcipotriol was administered twice daily for seven days before the start of photo provocation.
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Baseline characteristics reporting groups
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Reporting group title |
Half-side treatment
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Reporting group description |
13 Patients were treated with Calcipotriol on one body side and Placebo on the other Body site. The intra- individual Body site to be treated was determined by randomization. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Before photo testing
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Before photo testing
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Subject analysis set title |
After photo testing
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
After photo testing
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End points reporting groups
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Reporting group title |
Half-side treatment
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Reporting group description |
13 Patients were treated with Calcipotriol on one body side and Placebo on the other Body site. The intra- individual Body site to be treated was determined by randomization. | ||
Subject analysis set title |
Before photo testing
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Before photo testing
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Subject analysis set title |
After photo testing
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
After photo testing
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End point title |
Polymorphic light eruption score | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-144 hours
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Statistical analysis title |
PLE score | ||||||||||||
Comparison groups |
Before photo testing v After photo testing
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Number of subjects included in analysis |
26
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
50
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
5 | ||||||||||||
upper limit |
95 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information [1]
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Timeframe for reporting adverse events |
From enrolment to last visit per patient
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
22.0
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Reporting groups
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Reporting group title |
Half-side treatment
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Reporting group description |
13 Patients were treated with Calcipotriol on one body side and Placebo on the other Body site. The intra- individual Body site to be treated was determined by randomization. | ||||||||||
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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: As expected, photo provocation did lead to occurrence of symptoms in 12 out of 13 patients. The occurrence of Symptoms in a circumscribed UV- exposed Body site is aim of the procedure and desired to quantify severity of disease. Therefore such symptoms cannot be considered as 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 |