Clinical Trial Results:
Open clinical study to determine the tolerability of Pyolysin®-Salbe in children aged between 0 and 17 years during the dermatological treatment of superficial wounds
Summary
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EudraCT number |
2011-002755-34 |
Trial protocol |
DE |
Global end of trial date |
03 Nov 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
15 May 2016
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First version publication date |
15 May 2016
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Other versions |
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Summary report(s) |
Synopsis SWB-06-11 |
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 |
SWB-06-11
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Serumwerk Bernburg AG
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Sponsor organisation address |
Hallesche Landstrasse 105b, Bernburg, Germany, 06406
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Public contact |
Susanne Manhart, Serumwerk Bernburg AG, 0049 03471860180, smanhart@serumwerk.de
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Scientific contact |
Susanne Manhart, Serumwerk Bernburg AG, 0049 03471860180, smanhart@serumwerk.de
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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 |
03 Nov 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Nov 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Nov 2014
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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 confirm the tolerability of the Pyolysin-Salbe in the age group from 0 to 17 years
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Protection of trial subjects |
The protocol and amendment were approved by local ethics committee and competent authority. The trial was conducted in accordance with good clinical practice and the Declaration of Helsinki. Informed consent was obtained in writing prior to any trial-related activities.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2012
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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 |
Germany: 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) |
3
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Adults (18-64 years) |
0
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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 |
Subjects were screened in the period 01.03.2012 until 03.11.2014 . The trial took place in one center in Germany. Examination of the wound and wound cleansing by physician, an overview of the wound conditions was gained and decided whether it was possible for the patient to participate in the Trial, only 3 patients of 120 planned were recruited | ||||||
Pre-assignment
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Screening details |
Screening of patients was performed using a screening form in selected doctors’ practices | ||||||
Pre-assignment period milestones
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Number of subjects started |
3 | ||||||
Number of subjects completed |
3 | ||||||
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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Group A | ||||||
Arm description |
7-17 years | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Pyolysin®-Salbe, Creme
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Investigational medicinal product code |
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Other name |
Pyolysin ointment
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Pharmaceutical forms |
Ointment
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Pyolysin® ointment is applied thinly to the affected area of skin twice daily (morning and evening). The area to be treated is defined or demarcated by a template (min. size 2 x 2 cm or 4 cm2; max. 8 x 8 cm or 64 cm2). This area is marked on the skin with a skin-tolerable permanent skin marker (Viomedex) with the aid of the template. This ensures that the ointment is applied correctly to the same area every day.
The treatment is continued up to a maximum of 3 weeks until wound healing is achieved.
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Baseline characteristics reporting groups
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Reporting group title |
Group A
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Reporting group description |
7-17 years | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
7-17 years |
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End point title |
Visual Score [1] | ||||||||||||||
End point description |
Tolerability (assessment based on clinical and subjective scores)
Visual Score: 0 = geheilt, 1 = leichte Rötung der Haut, 2 = Restschorf ohne Erosion, leichte Umgebungsrötung, 3 = Hauterosion, leichte Umgebungsentzündung, 4 = Hauterosion, Nässen, starke Umgebungsentzündung,
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End point type |
Primary
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End point timeframe |
Visit 0 (Day 0), Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3 or end)
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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: The planned methods of statistical Analysis could not be used because of the small number of 3 cases. |
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No statistical analyses for this end point |
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End point title |
SCORAD intensity of wound [2] | ||||||||||||||
End point description |
Tolerability (assessment based on clinical and subjective scores)
SCORAD: 0 = keine, 1 = leicht, 2 = mäßig, 3 = stark
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End point type |
Primary
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End point timeframe |
Visit 0 (Day 0), Visit 1 (week 1), Visit 2 (week2), visit 3 (week 3)
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Notes [2] - 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: The planned methods of statistical Analysis could not be used because of the small number of 3 cases. |
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No statistical analyses for this end point |
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End point title |
wound size | ||||||||||||||
End point description |
area of wound in cm2, additional information concerning the progress of wound healing
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End point type |
Secondary
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End point timeframe |
Visit 0 (Day 0), Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3)
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No statistical analyses for this end point |
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End point title |
Skin temperature wound | ||||||||||||
End point description |
measurement of skin temperature of the wound, additional information concerning the progress of wound healing
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End point type |
Secondary
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End point timeframe |
Visit 0 (Day 0), Visit 1 (week 1), Visit 2 (week 2), Visit 3 (week 3)
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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 |
3 patients received Pyolysin ointment thinly to the affected area of skin twice daily (morning and evening). Treatment Duration was 7, 10 and 14 days, respectively. No adverse Events have been observed.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
16
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Reporting groups
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Reporting group title |
Group A (7-17 years)
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Reporting group description |
3 patients | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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: due to insufficient recruitment only 3 patients were treated, there were no non-serious adverse events observed during this trial |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Dec 2013 |
amendment to the protocol, adaptation of the inclusion criteria, changes in Informed Consent form and CRF, Extension of the duration of the trial due to insufficient recruitment ( 3 patients of 120) |
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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. | |||
Due to insufficient recruitment only 3 patients were treated. |