Clinical Trial Results:
Mikroperfusions-Pilotstudie zur Korrelation von Schmerzreaktion und neurogener Entzündung bei photodynamischer Therapie superfizieller Basaliome
(English: Microperfusion-pilotstudy to correlate pain and neurogenic inflammation induced by photodynamic therapy of superficial basal cell carcinomas)
Summary
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EudraCT number |
2005-006136-29 |
Trial protocol |
AT |
Global end of trial date |
10 Jul 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Oct 2019
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First version publication date |
26 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 |
PDT-sBCC-MP-V1.0
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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 |
Auenbruggerplatz 8, Medical University of Graz, peter.wolf@medunigraz.at
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Scientific contact |
Auenbruggerplatz 8, 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 |
23 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Jul 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jul 2007
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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 test whether pretreatment of superficial basal cell carcinomas with capsaicin cream reduces neurogenic inflammation and pain during photodynamic treatment
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2007
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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: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
1
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment started in February 2007. The study was prematurely terminated in July 2007. The reason for the early termination was that the treatment schedule of four daily treatments over two weeks wasn't accepted by the patients. | ||||||
Pre-assignment
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Screening details |
3 patients provided Informed Consent and received 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 |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Half side treatment | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Capsaicin
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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 |
0,05% Capsaicin cream, administered four times daily over the Course of two weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
- |
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End point title |
Visual Analogue Scale for Pain (VAS) [1] | |||
End point description |
None of the predefined end Points were analysed since the study was terminated prematurely.
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End point type |
Primary
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End point timeframe |
24 hours
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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: None of the predefined end Points were analysed since the study was terminated prematurely. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From enrolment to informed consent
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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 |
Capsaicin cream
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Vehicle cream
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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: Pain is a typical side effect of photodynamic therapy (PDT). The study was designed to reduce PDT- associated pain by pre-treatment with Capsaicin cream. Pain was an absolute prerequisite to evaluate the study end point. Therefore PDT-associated pain was not considered as Adverse Event. |
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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 |