Clinical Trial Results:
Photodynamic therapy for skin rejuvenation: A pilotstudy evaluating the
effectiveness of 5-aminolevulinic acid -based photodynamic therapy in the
treatment of photodamaged skin
Summary
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EudraCT number |
2015-002537-22 |
Trial protocol |
AT |
Global end of trial date |
23 Jan 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Sep 2020
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First version publication date |
04 Sep 2020
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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-PR1
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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 Wien, Univ. Klinik f. Dermatologie
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienna, Austria,
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Public contact |
Univ. Klinik fuer Dermatologie, Medizinische Universitaet Wien, Univ. Klinik fuer Dermatologie, +43 14040077020, sonja.radakovic@meduniwien.ac.at
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Scientific contact |
Univ. Klinik fuer Dermatologie, Medizinische Universitaet Wien, Univ. Klinik fuer Dermatologie, +43 14040077020, sonja.radakovic@meduniwien.ac.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 Jun 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Aug 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jan 2018
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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 |
Evaluating the effectiveness of ALA-PDT in patients with photodameged skin concerning cosmetic results and skinageing 6 months after treatment
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Protection of trial subjects |
insurance, patient informed consent
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Jan 2017
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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) |
9
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From 65 to 84 years |
2
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85 years and over |
2
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Recruitment
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Recruitment details |
13 Patients were recruited between January 2017 and September 2017 | ||||||
Pre-assignment
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Screening details |
general medical history, clinical status, informed consent | ||||||
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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ALA- PDT | ||||||
Arm description |
- | ||||||
Arm type |
ALA-PDT therapy | ||||||
Investigational medicinal product name |
5-aminolaevulinic acid (Ameluz)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Cutaneous use
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Dosage and administration details |
BF-200 aminolaevulinic acid was applied to the face 90 minutes before red-light PDT treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ALA- PDT
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Reporting group description |
- |
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End point title |
Changes of the Photoaging Score [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months after first PDT treatment
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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: A clinical photoaging score to analyse visual signs of skin ageing was assessed in patients with photodameged skin at baseline and six months after the first treatment. Only descriptive statistics were used. |
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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 |
between patient inclusion and last visit
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
18
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Reporting groups
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Reporting group title |
ALA-PDT
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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? Yes | |||
Date |
Amendment |
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02 Jan 2017 |
inclusion criteria: age 45-90 |
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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. | |||
None reported |