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)

Trial information Top of page
Trial identification
Sponsor protocol code	PDT-sBCC-MP-V1.0
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Medical University of Graz
Sponsor organisation address	Auenbruggerplatz 8, Graz, Austria, 8036
Public contact	Auenbruggerplatz 8, Medical University of Graz, peter.wolf@medunigraz.at
Scientific contact	Auenbruggerplatz 8, Medical University of Graz, peter.wolf@medunigraz.at
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	23 Feb 2015
Is this the analysis of the primary completion data?	Yes
Primary completion date	10 Jul 2007
Global end of trial reached?	Yes
Global end of trial date	10 Jul 2007
Was the trial ended prematurely?	Yes
General information about the trial
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
Protection of trial subjects	The study was approved by the local Ethics Committee and was conducted according to the principles of Good Clinical Practice.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	01 Feb 2007
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Austria: 3
Worldwide total number of subjects	3
EEA total number of subjects	3
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	1
From 65 to 84 years	2
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
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
Screening details	3 patients provided Informed Consent and received Treatment.
Period 1
Period 1 title	Overall trial (overall period)
Is this the baseline period?	Yes
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Arm title	Half side treatment
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Capsaicin
Investigational medicinal product code
Other name
Pharmaceutical forms	Cream
Routes of administration	Cutaneous use
Dosage and administration details	0,05% Capsaicin cream, administered four times daily over the Course of two weeks
Number of subjects in period 1 Half side treatment Started 3 Completed 3

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Overall trial
Reporting group description	-
Reporting group values Overall trial Total Number of subjects 3 3 Age categorical Units: Subjects     In utero 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0     Newborns (0-27 days) 0 0     Infants and toddlers (28 days-23 months) 0 0     Children (2-11 years) 0 0     Adolescents (12-17 years) 0 0     Adults (18-64 years) 1 1     From 65-84 years 2 2     85 years and over 0 0 Gender categorical Units: Subjects     Female 1 1     Male 2 2

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Half side treatment
Reporting group description	-

End points Top of page

Primary: Visual Analogue Scale for Pain (VAS) Top of page
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.
End point type	Primary
End point timeframe	24 hours
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.
End point values Number of subjects analysed Units: Units on VAS
No statistical analyses for this end point

Primary: Visual Analogue Scale for Pain (VAS) Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	From enrolment to informed consent
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	22.0
Reporting groups
Reporting group title	Capsaicin cream
Reporting group description	-
Reporting group title	Vehicle cream
Reporting group description	-
Serious adverse events Capsaicin cream Vehicle cream Total subjects affected by serious adverse events      subjects affected / exposed 0 / 3 (0.00%) 0 / 3 (0.00%)      number of deaths (all causes) 0 0      number of deaths resulting from adverse events 0 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Capsaicin cream Vehicle cream Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 3 (0.00%) 0 / 3 (0.00%)
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.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

More information Top of page