Clinical Trial Results:
Daylight-PDT in the treatment of actinic keratosis: a pilot study comparing two different light sensitizers
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Summary
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EudraCT number |
2013-001389-40 |
Trial protocol |
FI |
Global end of trial date |
11 Feb 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Feb 2025
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First version publication date |
14 Feb 2025
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Other versions |
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Summary report(s) |
Publication |
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 |
phch2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02149342 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Joint Authority for Päijät-Häme Social and health care group
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Sponsor organisation address |
Keskussairaalankatu 7, Lahti, Finland, 15850
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Public contact |
Mari Grönroos, Mari Grönroos, mari.gronroos@co.inet.fi
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Scientific contact |
Mari Grönroos, Mari Grönroos, mari.gronroos@co.inet.fi
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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 |
11 Feb 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Feb 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Feb 2016
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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 |
Comparing the histological and clinical efficacy of two light sensitizers in the daylight-PDT treatment of actinic keratosis
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Protection of trial subjects |
We used a treatment protocol using daylight as a light source. This has previously been shown as painless and cause less adverce effects compared to traditional treatment with LED light
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Mar 2014
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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 |
Finland: 28
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Worldwide total number of subjects |
28
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EEA total number of subjects |
28
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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) |
0
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From 65 to 84 years |
20
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85 years and over |
8
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Recruitment
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Recruitment details |
Inclusion criteria were pateints with at least two actinic keratoses ≥ 6 mm in diameter symmetrically on the faces or scalp and equally clinically graded. | |||||||||
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Pre-assignment
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Screening details |
Clinical examination of the skin | |||||||||
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Period 1
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Period 1 title |
Treatment (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 | |||||||||
Blinding implementation details |
The randomization results (which tereatment side was treated with which photosensitizer) were kept blinded from the investigators who conducted the follow-up visits, and from the pathologist
and patients.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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HAL arm | |||||||||
Arm description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. In total, 14 patientes were recruited and treated in a slit-face design (in total 28 treatment halfs) | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
HAL
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Investigational medicinal product code |
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Other name |
hexyl-aminolaevulinate
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical, Topical use
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Dosage and administration details |
The topical photosensitizer HAL (Hexvix powder;Photocure ASA, Oslo, Norway), prepared to a 0.2% concentration
using a lipid-rich cream base (Unguentum M; Allmiral, Madrid, Spain)
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Arm title
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MAL arm | |||||||||
Arm description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
MAL
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Investigational medicinal product code |
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Other name |
methyl-aminolaevulinate
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use , Topical
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Dosage and administration details |
16% MAL cream (Metvix; Galderma,Paris, France)
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Baseline characteristics reporting groups [1]
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Reporting group title |
HAL arm
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Reporting group description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. In total, 14 patientes were recruited and treated in a slit-face design (in total 28 treatment halfs) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MAL arm
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Reporting group description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: The total number of patients was 14, they were treated in a split-face design (each patient was included in both arms) |
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End points reporting groups
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Reporting group title |
HAL arm
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Reporting group description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. In total, 14 patientes were recruited and treated in a slit-face design (in total 28 treatment halfs) | ||
Reporting group title |
MAL arm
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Reporting group description |
The treatments were given in a randomized, slit-face design, HAL on the other side and MAL on the other side symmetrically. | ||
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End point title |
Clinical lesion clearance | |||||||||
End point description |
The primary outcome measurement was lesion clearance (mean % of baseline lesions per patient who was 100% cleared).
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End point type |
Primary
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End point timeframe |
Three months after the treatment
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Statistical analysis title |
Clinical clearance | |||||||||
Statistical analysis description |
Wilcoxon signed rank test
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Comparison groups |
HAL arm v MAL arm
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.754 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
Histological clearance | |||||||||
End point description |
Secondary outcome measurements included histological clearance
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End point type |
Secondary
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End point timeframe |
Three months after the treatment
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Statistical analysis title |
Histological lesion clearance | |||||||||
Statistical analysis description |
Wilcoxon signed rank test
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Comparison groups |
MAL arm v HAL arm
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Number of subjects included in analysis |
26
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.289 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Pain during the treatment and adverse reactions measured separately for both treatment sides.
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Assessment type |
Systematic | ||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | ||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Pain
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Reporting group description |
Patients recorded pain separately on both sides using a visual analogue scale (VAS, 0-10) every 30 minutes during the 2-hour-daylight exposure and every 2 hours until 9 p.m. after therapy. | ||||||||||||||||||||||||
Reporting group title |
Adverse reactions
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Reporting group description |
Local adverse reactions (erythema, oedema, crusting) were assessed 6-7 days after the treatment and classified as follows: minimal I, mild II, intermediate III and severe IV by a blinded investigator. The assesment was done separately for both treatment sides. The reactions were minimal in 10 HAL and 3 MAL, mild in 3 HAL and 9 MAL, and intermediate in 1 HAL and 2 MAL sites | ||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||
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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. | |||
| The study used a "slit-face" design where the patients served as tehir own controls i.e. the total number or patients enrolled was 14 (two face halfs treated, totally 28). | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/26011755 |
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