Clinical Trial Results:
Die Bedeutung des sensorischen Nervensystems für
die Repigmentierung der Haut bei Vitiligo
(engl.: The role of the sensory nervous system for repigmentation in vitiligo)
Summary
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EudraCT number |
2006-000838-12 |
Trial protocol |
AT |
Global end of trial date |
05 Mar 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Oct 2019
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First version publication date |
05 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 |
Vit-Caps-Protocol-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 |
Medizinische Universität Graz
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Sponsor organisation address |
Auenbruggerplatz 8, Graz, Austria, 8036
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Public contact |
Prof. Franz Legat, Medizinische Universität Graz, 0043 31638580543, franz.legat@medunigraz.at
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Scientific contact |
Prof. Franz Legat, Medizinische Universität Graz, 0043 31638580543, franz.legat@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 |
05 Mar 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Mar 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Mar 2008
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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 repeated stimulation of the skin's sensory nervous system via cutaneous application of a capsaicin-containing cream affects the repigmentation of vitiliginous skin areas
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Protection of trial subjects |
The study was approved by the local Ethics Committee.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 May 2006
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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: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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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) |
7
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
7 patients were recruited for the study. Recruitment was teminated early in January 2007, since none of the included patients reached clinical repigmentation of vitiligo. | ||||||||||||
Pre-assignment
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Screening details |
There were no screening failures in this Trial. | ||||||||||||
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 |
Half-side Treatment study. All Patients were treated on lesional Skin on one Body site with Capsaicin containing cream. On the other Body site Vehicle cream was used. | ||||||||||||
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 |
Capsaicin 0,05% cream (in Diprosicc) versus Diprosicc three times/week (Monday, Wednesday, Friday) for a duration of 12 weeks, a total of 36 treatments.
There was also the option of a Treatment Prolongation for another 12 weeks.
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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 |
Half-side Treatment study. All Patients were treated on lesional Skin on one Body site with Capsaicin containing cream. On the other Body site Vehicle cream was used. | |||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
Half-side Treatment study. All Patients were treated on lesional Skin on one Body site with Capsaicin containing cream. On the other Body site Vehicle cream was used. |
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End point title |
Repigmentation of the skin [1] | ||||||||
End point description |
The End Point was not analysed, since the planned recruitment number could not be reached and the study was terminated prematurely.
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End point type |
Primary
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End point timeframe |
3 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: None of the predefined end points were analysed. The study was terminated prematurely because none of the included patients showed repigmentation of vitiligo on either treatment side. |
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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 |
From time of informed consent to last follow-up visit.
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
From informed consent to end of follow-up
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Reporting group description |
- | ||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||
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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 |