Clinical Trial Results:
Pretreatment with ablative fractional laser and microdermabrasion before photodynamic therapy for actinic keratoses in field-cancerized skin
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Summary
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EudraCT number |
2015-002331-18 |
Trial protocol |
DK |
Global end of trial date |
01 Oct 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Jun 2022
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First version publication date |
21 Jun 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 |
48739
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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 |
Bispebjerg Hospital, Department of Dermatology
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Sponsor organisation address |
Nielsine Nielsensvej 9, Copenhagen, Denmark,
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Public contact |
Katrine Togsverd-Bo, Bispebjerg Hospital, Department of dermatology, 0045 53539178, katrinetogsverd@hotmail.com
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Scientific contact |
Katrine Togsverd-Bo, Bispebjerg Hospital, Department of dermatology, 0045 53539178, katrinetogsverd@hotmail.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 |
07 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 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 |
Comparison of treatment efficacy of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses
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Protection of trial subjects |
Patients were followed up closely and were offered pain relief for topical interventions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 May 2016
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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 |
Denmark: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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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) |
3
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From 65 to 84 years |
14
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85 years and over |
1
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Recruitment
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Recruitment details |
patients were recruited from the hospitals outpatient clinic | |||||||||
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Pre-assignment
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Screening details |
Patients were to have clinical AKs in two side-by-side skin areas within the same anatomic location on the face, scalp, or chest with at least 5 AKs. Patients with porphyria, infiltrating tumors in treatment areas, pregnancy, lactation, or AK treatment in study areas 4 weeks before inclusion | |||||||||
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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 |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Blinding implementation details |
Blinded clinical evaluation of primary end point (AK)
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Arms
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Are arms mutually exclusive |
No
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Arm title
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AFL- PDT | |||||||||
Arm description |
Ablative fractional laser combined with daylight photodynamic therapy | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
methyl aminolevulinate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream + pessary
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Routes of administration |
Topical use
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Dosage and administration details |
MAL cream applied in 0.3-0.5 mm thickness to the treatment area. Up to 1 g.
One treatment
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Arm title
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MD PDT | |||||||||
Arm description |
Microdermabrasion pretreatment performed prior to photodynamic therapy | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
methyl aminolevulinate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream + pessary
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Routes of administration |
Topical use
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Dosage and administration details |
MAL cream applied in 0.3-0.5 mm thickness to the treatment area. Up to 1 g.
One treatment
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
AK response
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
18 participants were included as a preemptive measure against drop-out. AK clearance rates and patientreported
pain was analyzed using paired t-tests after Shapiro-Wilk test confirmed normal
distribution.
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End points reporting groups
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Reporting group title |
AFL- PDT
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Reporting group description |
Ablative fractional laser combined with daylight photodynamic therapy | ||
Reporting group title |
MD PDT
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Reporting group description |
Microdermabrasion pretreatment performed prior to photodynamic therapy | ||
Subject analysis set title |
AK response
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
18 participants were included as a preemptive measure against drop-out. AK clearance rates and patientreported
pain was analyzed using paired t-tests after Shapiro-Wilk test confirmed normal
distribution.
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End point title |
AK lesion response | ||||||||||||
End point description |
s AK complete response (CR) rate, defined as the number of
cleared AKs at 3-months follow-up, divided by AK number at baseline. Two blinded evaluators
(E.W. and C.B.) assessed areas visually and by palpation.
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End point type |
Primary
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End point timeframe |
3 months after treatment
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Statistical analysis title |
paired t test | ||||||||||||
Statistical analysis description |
paired test as intra-individual design
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Comparison groups |
AFL- PDT v MD PDT
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Number of subjects included in analysis |
36
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
local skin response | |||||||||||||||||||||
End point description |
redness, edema, flaking, sores, crusting, pustules and erosions. Each parameter
was graded on 4-point severity scale (0-3) representing none, mild, moderate and severe. A
total composite score reflecting overall LSR severity was then calculated based on the sum of
all parameters
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End point type |
Secondary
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End point timeframe |
Days 1-2, 3-6, 7-14 and Weeks 12-15,
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Photodamage improvement | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
improvement weeks 12-15 from baseline
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Statistical analysis title |
Wilcoxon signed rank test | ||||||||||||
Comparison groups |
AFL- PDT v MD PDT
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Number of subjects included in analysis |
36
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
dyspigmentation | ||||||||||||||||||||
End point description |
hyper-, or hypopigmentation during the study period graded on 4-point categorical scale
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End point type |
Secondary
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End point timeframe |
week 12-15
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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 |
15 weeks after study inclusion
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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 |
10
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
- | ||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0.5% | |||||||||||||||||
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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 | |||
