Clinical Trial Results:
A Multicenter, Double blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratoses on the Face and/or Scalp
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Summary
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EudraCT number |
2005-005015-13 |
Trial protocol |
DE |
Global end of trial date |
23 Jan 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jul 2022
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First version publication date |
07 Jul 2022
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Other versions |
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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 |
PC T405/05
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00304239 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Galderma R&D SNC
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Sponsor organisation address |
Les Templiers, 2400 route des colles, Biot, France, 06410
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Public contact |
CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
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Scientific contact |
CTA Coordinator, Galderma R&D SNC, +33 (0)493-95-70-85, cta.coordinator@galderma.com
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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 Jan 2007
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jan 2007
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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 |
The main objective of this trial was to compare the subject complete response rate of Metvix® Photodynamic Therapy (PDT) to that of vehicle PDT 3 months after last treatment in subjects with multiple Actinic Keratoses (AK) lesions on the face and/or scalp.
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Protection of trial subjects |
The study was conducted in accordance with the principles of the Declaration of Helsinki, 1964, as amended in Edinburgh, United Kingdom (UK), 2000, and in compliance with the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), as described in the European Medicines Agency (EMEA) Note for Guidance on Good Clinical Practice, committee for Proprietary Medicinal Products, CPMP/ICH/135/95, in operation 17 January 1997, and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Mar 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 |
Germany: 83
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Country: Number of subjects enrolled |
United States: 48
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Worldwide total number of subjects |
131
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EEA total number of subjects |
83
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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) |
37
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From 65 to 84 years |
86
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85 years and over |
8
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Recruitment
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Recruitment details |
The study was conducted at 12 centers in Germany and the United States between 13 March 2006 to 23 January 2007. | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 131 subjects were enrolled and received treatment in this study. | ||||||||||||||||||
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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 |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Metvix-PDT | ||||||||||||||||||
Arm description |
Metvix (methyl aminolevulinate hydrochloride) 160 milligrams per gram (mg/g) cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Metvix 160 mg/g Cream
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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 |
Topical use
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Dosage and administration details |
Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule per square centimeter (J/cm^2). All eligible lesions on the subject were treated twice with an interval of 1 week between treatments.
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Arm title
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Vehicle-PDT | ||||||||||||||||||
Arm description |
Vehicle cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Vehicle-PDT
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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 |
Topical use
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Dosage and administration details |
Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite® CL128 lamp, with a total light dose 37 J/cm^2. All eligible lesions on the subject were treated twice with an interval of 1 week between treatments.
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Baseline characteristics reporting groups
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Reporting group title |
Metvix-PDT
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Reporting group description |
Metvix (methyl aminolevulinate hydrochloride) 160 milligrams per gram (mg/g) cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle-PDT
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Reporting group description |
Vehicle cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Metvix-PDT
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Reporting group description |
Metvix (methyl aminolevulinate hydrochloride) 160 milligrams per gram (mg/g) cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||
Reporting group title |
Vehicle-PDT
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Reporting group description |
Vehicle cream was applied to face and or scalp at Day 0 and at Day 7 where other therapies were unacceptable or considered medically less appropriate. | ||
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End point title |
Percentage of Subjects With Complete Response [1] | ||||||||||||
End point description |
Subject complete response was defined as the percentage of subjects with all treated lesions that were assessed as clear and/or on face and scalp at 3 months after treatment determined by clinical assessment (visual inspection and palpation). Percentage of subjects with complete response at 3 months after treatment was reported. The analysis was performed on the intention-to-treat (ITT) population which consisted of all subjects that were randomized and for whom any aspect of treatment with either Metvix-PDT or Vehicle-PDT was initiated.
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End point type |
Primary
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End point timeframe |
Up to 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: Only descriptive data was planned to be analyzed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Lesion Complete Response | ||||||||||||
End point description |
Lesion complete response was defined as the percentage of pre-existing and treated lesions that were assessed as clear on face and scalp 3 months after treatment. Percentage of lesions after 3 months of treatment was reported. The analysis was performed on the ITT population which consisted of all subjects that were randomized and for whom any aspect of treatment with either Metvix-PDT or Vehicle-PDT was initiated.
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End point type |
Secondary
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End point timeframe |
Up to 3 months
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With at Least One Treatment Site Adverse Events | |||||||||
End point description |
An AE was any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of subjects with at least one treatment site adverse events were reported. The safety population consisted of all subjects for whom any kind of treatment was initiated.
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End point type |
Secondary
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End point timeframe |
Up to 3 Months
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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 study drug administration up to 3 Months
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Adverse event reporting additional description |
The safety population consisted of all subjects for whom any kind of treatment was initiated.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
8.0
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Reporting groups
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Reporting group title |
Metvix® (methyl aminolevulinate hydrochloride)-PDT
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Reporting group description |
Metvix® 160 milligrams/gram (mg/g) Cream (active IMP) was applied to face/scalp where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle-PDT
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Reporting group description |
Vehicle cream was applied to face/scalp where other therapies were unacceptable or considered medically less appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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04 Nov 2005 |
The safety follow-up visit was scheduled 2 weeks after last treatment. |
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02 May 2006 |
The protocol was updated to perform the study in Germany and United Kingdom. However, the study was initiated only in Germany. Subsequently, the study was expanded to include 4 centers in the United States and to extend the recruitment period due to slower than expected enrollment in the original German centers. |
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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 | |||
