Clinical Trial Results:
A Phase II/III Adaptive, Seamless, Prospective, Randomized, Controlled, Parallel, Open Multicenter Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulfadiazine (Dermazin®, SSD) Therapy in the Wound Healing of Patients With Partial Thickness (Second-Degree) Burns
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Summary
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EudraCT number |
2013-005124-42 |
Trial protocol |
HU |
Global end of trial date |
29 Jul 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Dec 2021
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First version publication date |
05 Dec 2021
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Other versions |
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Summary report(s) |
Report Synopsis |
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 |
KEKLUKACS-CLIN-02
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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 |
Lukács és Társa Gyógyszerkereskedelmi Betéti TársaságLukács és Társa Gyógyszerkereskedelmi Betéti Társaság
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Sponsor organisation address |
Mártírok street 53, Iharosberény, Hungary, 8725
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Public contact |
KÉKLUKÁCS Help Desk, AdWare Research Ltd., 36 87789073, info@adwareresearch.com
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Scientific contact |
KÉKLUKÁCS Help Desk, AdWare Research Ltd., 36 87789073, info@adwareresearch.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 |
22 Oct 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jul 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jul 2015
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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 |
Primary objective
To compare the clinical efficacy of Kék Lukács ointment treatment with standard Dermazin® (SSD) therapy in wound healing; with 3D photo documentary every second day from the first day of treatment till the 22th day of treatment or till healing of the wound; by evaluating the days needed to the wound healing.
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Protection of trial subjects |
In case of considerable wound pain, commonly used pain-killer medication (paracetamol, diclofenac, ibuprofen) are allowed. Necessity of analgesics and their exact dosage is recorded in the Nurse Booklet.
Other routine medical treatments for concomitant diseases are allowed and accurately recorded.
Other burned wounds of patients will be treated according to the Investigator’s decision.
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Background therapy |
In case of considerable wound pain, commonly used pain-killer medication (paracetamol, diclofenac, ibuprofen) are allowed. Necessity of analgesics and their exact dosage is recorded in the Nurse Booklet. Other routine medical treatments for concomitant diseases are allowed and accurately recorded. Other burned wounds of patients will be treated according to the Investigator’s decision. | ||
Evidence for comparator |
Control group in the study was randomized to SSD, Dermazin® cream treatment group. Dosage and administration: The cream should be applied to a thickness between 2-4 mm onto the sterile gauze before covering the burned surface once daily until wound healing. | ||
Actual start date of recruitment |
03 Mar 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Hungary: 73
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Worldwide total number of subjects |
73
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EEA total number of subjects |
73
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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) |
63
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From 65 to 84 years |
9
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85 years and over |
1
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
On Day 1 at first visit, patients will undergo screening for inclusion/exclusion criteria after having provided a written Informed Consent. | |||||||||
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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 |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Locally applied Kék Lukács ointment | |||||||||
Arm description |
The ointment should be applied to a thickness between 1-2 mm (maximum 40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Kék Lukács Ointment
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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 |
External use
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Dosage and administration details |
The ointment should be applied to a thickness between 1-2 mm onto the sterile gauze before covering the burned surface once daily until wound healing.
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Arm title
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SSD, Dermazin® cream | |||||||||
Arm description |
The cream should be applied to a thickness between 2-4 mm (maximum 20-40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Dermazin®
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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 |
External use
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Dosage and administration details |
The cream should be applied to a thickness between 2-4 mm onto the sterile gauze before covering the burned surface once daily until wound healing.
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Baseline characteristics reporting groups
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Reporting group title |
Locally applied Kék Lukács ointment
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Reporting group description |
The ointment should be applied to a thickness between 1-2 mm (maximum 40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SSD, Dermazin® cream
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Reporting group description |
The cream should be applied to a thickness between 2-4 mm (maximum 20-40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | ||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Intent-to-treat (ITT) analysis set
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised subjects who received at least one study treatment and had at least one postbaseline evaluation of the target wound area.
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Subject analysis set title |
Per protocol (PP) analysis set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised subjects who received at least one study treatment and had at least one postbaseline evaluation of the target wound area and did not have any major protocol deviations
(protocol violation). Protocol violation included:
violation of any inclusion/exclusion criterion
randomisation error
use of any prohibited systemic or topical medication on the test site and/or on other
(non-target) burn area(s)
missing more than one clinical visits (treatment and/or follow-up).
Patients who experienced deterioration of the target wound due to treatment failure and
needed therefore skin transplantation on the target wound were withdrawn from the study. If
the surgery area exceeded 50% of the original wound area the patient was excluded from the
PP analysis. If the surgery area did not exceed 50% of the original wound area the patient
remained in the PP analysis set and the healing of the wound area outside the surgical area
was taken into account for the analy
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised subjects who received at least one study treatment.
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End points reporting groups
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Reporting group title |
Locally applied Kék Lukács ointment
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Reporting group description |
The ointment should be applied to a thickness between 1-2 mm (maximum 40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | ||
Reporting group title |
SSD, Dermazin® cream
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Reporting group description |
The cream should be applied to a thickness between 2-4 mm (maximum 20-40 g/400 cm2) onto the gauze before covering the selected burned surface once daily until wound healing. | ||
Subject analysis set title |
Intent-to-treat (ITT) analysis set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All randomised subjects who received at least one study treatment and had at least one postbaseline evaluation of the target wound area.
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Subject analysis set title |
Per protocol (PP) analysis set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All randomised subjects who received at least one study treatment and had at least one postbaseline evaluation of the target wound area and did not have any major protocol deviations
(protocol violation). Protocol violation included:
violation of any inclusion/exclusion criterion
randomisation error
use of any prohibited systemic or topical medication on the test site and/or on other
(non-target) burn area(s)
missing more than one clinical visits (treatment and/or follow-up).
Patients who experienced deterioration of the target wound due to treatment failure and
needed therefore skin transplantation on the target wound were withdrawn from the study. If
the surgery area exceeded 50% of the original wound area the patient was excluded from the
PP analysis. If the surgery area did not exceed 50% of the original wound area the patient
remained in the PP analysis set and the healing of the wound area outside the surgical area
was taken into account for the analy
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Subject analysis set title |
Safety analysis set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All randomised subjects who received at least one study treatment.
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End point title |
Wound healing | |||||||||||||||
End point description |
The primary endpoint of this study will be the number of days until wound healing. Wound healing will be attained on the first day when the wound area (as measured by planimetry, taking the mean of the values evaluated by two independent assessors) will be below 10% of the baseline wound area. Wound area will be measured in each two days starting from baseline, and no interpolation for wound area will be performed.
A wound is considered to be healed on the first day when the unhealed wound extent decreases under 10% of the original wound extent. For patients by whom treatment was continued by surgery the day of ordering surgery will be taken into consideration.
If the surgery area extends 50% of the original wound area the patient will be excluded from the analysis of PP population. By the analysis the healing of the wound area outside the surgical area will be taken into account.
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End point type |
Primary
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End point timeframe |
from baseline until wound healing
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Statistical analysis title |
Primary Efficacy Endpoint | |||||||||||||||
Comparison groups |
Locally applied Kék Lukács ointment v SSD, Dermazin® cream
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0001 | |||||||||||||||
Method |
t-test, 1-sided | |||||||||||||||
Confidence interval |
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Statistical analysis title |
Primary Efficacy Endpoint | |||||||||||||||
Comparison groups |
Locally applied Kék Lukács ointment v SSD, Dermazin® cream
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
< 0.0001 | |||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||||||||
Confidence interval |
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End point title |
Signs of wound infection and Inflammation | ||||||||||||
End point description |
Investigator‘s assessment of signs of wound infection and inflammation: a) oozing, b)
erythema, c) warmth, d) oedema, e) pain, f) odour on each medical visit in treatment and
follow up periods of the study
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End point type |
Secondary
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End point timeframe |
From Visit 1 to Follow-up Visit 2
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Statistical analysis title |
Signs of wound infection and Inflammation | ||||||||||||
Statistical analysis description |
The following secondary efficacy parameters were evaluated:
- signs of wound infection
- inflammation
- pain scores
- cosmetic results
The proportions of number of subjects healed until a certain day were calculated and compared
between treatment arms, with 95% confidence intervals.
- percent reduction of wound area
- wound margin
- wound bed
- wound surface
- wound secretion
- proportion of subjects receiving skin transplantation
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Comparison groups |
SSD, Dermazin® cream v Locally applied Kék Lukács ointment
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Confidence interval |
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End point title |
Wound-related mean pain scores | ||||||||||||
End point description |
Wound related pain after treatment
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End point type |
Secondary
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End point timeframe |
From study day 1 to day 29
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Cosmetic Results | |||||||||
End point description |
Comprising only subjects with not censored data
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End point type |
Secondary
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End point timeframe |
From Visit 3 to Follow-up visit 2
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Statistical analysis title |
General Cosmetic Results | |||||||||
Comparison groups |
SSD, Dermazin® cream v Locally applied Kék Lukács ointment
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Number of subjects included in analysis |
73
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.001 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
From 19.06.2014 to 29.04.2015
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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 |
17.0
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Reporting groups
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Reporting group title |
Severity
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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28 Feb 2014 |
The reason of the modification is the notes of ETT and GYEMSZI-OGYI to the first version of the protocol (December 16, 2013)
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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 | |||
