Clinical Trial Results:
Randomised, double-blind, bilateral comparison of two emollients in patients with dry skin.
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Summary
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EudraCT number |
2014-001026-16 |
Trial protocol |
GB |
Global end of trial date |
12 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Mar 2017
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First version publication date |
08 Mar 2017
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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 |
DELP-05
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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 |
Dermal Laboratories Limited
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Sponsor organisation address |
Tatmore Place, Gosmore, Hitchin, United Kingdom, SG4 7QR
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Public contact |
Clinical Trials Administrator, Dermal Laboratories Limited, 0044 1462458866, clinical@dermal.co.uk
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Scientific contact |
Clinical Trials Administrator, Dermal Laboratories Limited, 0044 1462458866, clinical@dermal.co.uk
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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 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Jun 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 |
The primary objective was to compare (bilaterally) Doublebase Dayleve Gel and Zerobase Emollient Cream, two moisturisers currently marketed in the UK, in terms of their cumulative effects on skin moisturisation levels (determined by corneometry), when applied twice daily by atopic eczema patients to their lower legs over 5 consecutive days. The secondary objective was to compare (bilaterally) the cosmetic acceptability of the two products. Each patient applied both study products: one to their left leg and the other to their right leg. The allocation of study products to left or right leg was randomised.
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Protection of trial subjects |
This was a low risk trial as the products tested are currently marketed in the UK and being used in accordance with their indication/ labelling instructions and current clinical practice. The main risk to participants was posed by them undergoing a 1 week washout period as part of the screening process; whereby they were asked not to apply any moisturisers to their lower legs only. This was mitigated by allowing the patients to carry on using their regular moisturisers/ treatments for managing their dry skin and eczema, apart from on their lower legs. In addition, only patients without active eczema flares on their lower legs were entered into the washout. Patients were also given the contact details of the study centre in case they had any concerns during this period, and in the unlikely event of their condition deteriorating, the Investigator would have immediately discontinued their participation in the study.
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Background therapy |
The use of the trial products was restricted to the patients' lower legs only. Elsewhere, they were allowed to carry on applying their usual topical treatments and moisturisers to manage their skin condition. | ||
Evidence for comparator |
The NICE Clinical Guideline for the management of atopic eczema advocates the frequent, widespread and liberal use of skin moisturisers, reapplied frequently throughout the day (even if the eczema is clear). However, this is not always practical and many patients are only able to apply their prescribed moisturisers in the morning and in the evening. This study was conducted to provide comparative evidence of the ability of moisturisers to improve and maintain skin hydration, when applied only twice daily. Therefore, both products selected for testing in this trial are popular moisturisers currently prescribed in the UK for the management of dry skin conditions such as atopic eczema. | ||
Actual start date of recruitment |
28 Apr 2015
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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 |
United Kingdom: 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) |
17
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Potential participants were primarily identified from a review of the study centre's patient volunteer database. In addition, a study poster was used in order to publicise the study to the wider community. | |||||||||
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Pre-assignment
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Screening details |
24 potential participants were consented and screened, 3 failed screening prior to washout. 21 patients commenced the one week washout period, of whom 18 were eligible for the study after completing the washout period and were randomised to the 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, Monitor, Data analyst, Assessor | |||||||||
Blinding implementation details |
For blinding purposes, the two products were repackaged into identical tubes and labelled with identical labels with the exception of the assigned patient number and right/ left lower leg allocation. Every patient number was unique and was related to the randomisation code pre-assigned by the statistician. In addition, the assessor was not allowed to witness the product application performed every morning (by the patient) at the study centre, nor see the actual content of the tubes.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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DELP Gel treated legs | |||||||||
Arm description |
Each patient applied both treatments, one to each left or right lower leg (randomised treatment allocation). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
DELP Gel
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Investigational medicinal product code |
PR1
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Other name |
Doublebase Dayleve (PL 00173/0199)
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Pharmaceutical forms |
Gel
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The product was applied topically by the patient, twice daily - once in the morning (at the study centre) between 8 and 10 am and once in the evening (at home) between 8 and 10 pm; for 5 days. Patients were instructed in their treatment diary to apply enough of each product to treat the assigned lower leg (from the ankle to the knee). As a guide, an amount of about 1 inch of product squeezed from the tube, or a blob about the size of a 20p piece, was instructed. This unit dose is consistent with the normal use of the products and current clinical practice.
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Arm title
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ZBC treated legs | |||||||||
Arm description |
Each patient applied both treatments, one to each left or right lower leg (randomised treatment allocation). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
ZBC
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Investigational medicinal product code |
PR2
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Other name |
Zerobase Emollient Cream
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Pharmaceutical forms |
Cream
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Routes of administration |
Cutaneous use
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Dosage and administration details |
The product was applied topically by the patient, twice daily - once in the morning (at the study centre) between 8 and 10 am and once in the evening (at home) between 8 and 10 pm; for 5 days. Patients were instructed in their treatment diary to apply enough of each product to treat the assigned lower leg (from the ankle to the knee). As a guide, an amount of about 1 inch of product squeezed from the tube, or a blob about the size of a 20p piece, was instructed. This unit dose is consistent with the normal use of the products and current clinical practice.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
All randomised patients. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Full Analysis Set was defined as all randomised subjects provided that they had a baseline measurement of corneometry. Since all randomised patients had a baseline measurement of corneometry the Full Analysis Set and the Safety Analysis Set were the same and included all randomised patients. The Full Analysis Set was used for the ITT analysis.
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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 |
The Safety Analysis Set comprised of all randomised patients who used at least one of the study products. All safety analyses were based on the Safety Analysis Set.
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End points reporting groups
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Reporting group title |
DELP Gel treated legs
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Reporting group description |
Each patient applied both treatments, one to each left or right lower leg (randomised treatment allocation). | ||
Reporting group title |
ZBC treated legs
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Reporting group description |
Each patient applied both treatments, one to each left or right lower leg (randomised treatment allocation). | ||
Subject analysis set title |
Full analysis set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set was defined as all randomised subjects provided that they had a baseline measurement of corneometry. Since all randomised patients had a baseline measurement of corneometry the Full Analysis Set and the Safety Analysis Set were the same and included all randomised patients. The Full Analysis Set was used for the ITT analysis.
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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 |
The Safety Analysis Set comprised of all randomised patients who used at least one of the study products. All safety analyses were based on the Safety Analysis Set.
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End point title |
DELP Gel vs ZBC: AUC change from baseline over 5 days | ||||||||||||
End point description |
The primary endpoint was the area under the curve (AUC) of the change from baseline (i.e. Day 1 pre-treatment) of the skin corneometry measurements collected for each leg over a 5 day period for DELP compared to that for ZBC. AUC was calculated using the Trapezoidal rule from the mean of triplicate measurements and using the actual time recorded on the CRF for the corneometry measurements rather than the scheduled time.
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End point type |
Primary
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End point timeframe |
Corneometry readings were obtained three times a day at approx. 4 hour intervals: first measurement in the morning around 9 am before product application, followed by the second measurement at around 1 pm and the third measurement at around 5 pm.
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| Notes [1] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. [2] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. |
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Statistical analysis title |
Treatment effect DELP Gel vs ZBC | ||||||||||||
Statistical analysis description |
The primary endpoint was analysed using a mixed model taking into account the within-patient design, with patient as a random effect and leg, randomised group and treatment as fixed effects and with baseline corneometry measurement as a covariate. The number of patients included in this analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis.
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Comparison groups |
DELP Gel treated legs v ZBC treated legs
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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 [3] | ||||||||||||
P-value |
< 0.0001 [4] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
1601
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
1277 | ||||||||||||
upper limit |
1924 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
151.7
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| Notes [3] - The number of patients included in this analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The parameter estimate is the least squares mean treatment difference for the AUC change from baseline corneometry readings over the 5 day period. [4] - Significant at 5% level (2-sided). |
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End point title |
DELP Gel vs ZBC: Change from baseline to first corneometry measurement on day 5 | ||||||||||||
End point description |
Secondary endpoints were the comparison between DELP Gel and ZBC in the change from baseline to the first corneometry measurement obtained on each of days 2 to 5. Since this is actually four secondary endpoints, a hierarchical testing regime, starting from day 5 through to day 2, was used to preserve the overall significance level. This is the day 5 secondary endpoint.
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End point type |
Secondary
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End point timeframe |
Corneometry readings for this endpoint were obtained on the first measurement in the morning (around 9 am) of days 1 (baseline) and 5; before the first morning application on the day.
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| Notes [5] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. [6] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. |
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Statistical analysis title |
Treatment effect DELP Gel vs ZBC | ||||||||||||
Statistical analysis description |
This secondary endpoint was analysed using a mixed model taking into account the within-patient design, with patient as a random effect and leg, randomised group and treatment as fixed effects and with baseline corneometry measurement as a covariate. The number of patients included in each analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis.
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Comparison groups |
DELP Gel treated legs v ZBC treated legs
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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 [7] | ||||||||||||
P-value |
< 0.0001 [8] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
12.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
8.4 | ||||||||||||
upper limit |
16.8 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.97
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| Notes [7] - The number of patients included in this analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). Parameter estimate is least squares mean treatment difference for the change from baseline to the first corneometry reading on day 5. [8] - A hierarchical testing regime was used, starting from day 5 through to day 2, to preserve the overall significance level (significant at 5% level, 2-sided). |
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End point title |
DELP Gel vs ZBC: Change from baseline to first corneometry measurement on day 4 | ||||||||||||
End point description |
Secondary endpoints were the comparison between DELP Gel and ZBC in the change from baseline to the first corneometry measurement obtained on each of days 2 to 5. Since this is actually four secondary endpoints, a hierarchical testing regime, starting from day 5 through to day 2, was used to preserve the overall significance level. This is the day 4 secondary endpoint.
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End point type |
Secondary
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End point timeframe |
Corneometry readings for this endpoint were obtained on the first measurement in the morning (around 9 am) of days 1 (baseline) and 4; before the first morning application on the day.
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| Notes [9] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. [10] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. |
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Statistical analysis title |
Treatment effect DELP Gel vs ZBC | ||||||||||||
Statistical analysis description |
This secondary endpoint was analysed using a mixed model taking into account the within-patient design, with patient as a random effect and leg, randomised group and treatment as fixed effects and with baseline corneometry measurement as a covariate. The number of patients included in each analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis.
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Comparison groups |
DELP Gel treated legs v ZBC treated legs
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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 [11] | ||||||||||||
P-value |
< 0.0001 [12] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
16.3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
12.3 | ||||||||||||
upper limit |
20.4 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.89
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| Notes [11] - The number of patients included in this analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). Parameter estimate is least squares mean treatment difference for the change from baseline to the first corneometry reading on day 4. [12] - A hierarchical testing regime was used, starting from day 5 through to day 2, to preserve the overall significance level (significant at 5% level, 2-sided). |
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End point title |
DELP Gel vs ZBC: Change from baseline to first corneometry measurement on day 3 | ||||||||||||
End point description |
Secondary endpoints were the comparison between DELP Gel and ZBC in the change from baseline to the first corneometry measurement obtained on each of days 2 to 5. Since this is actually four secondary endpoints, a hierarchical testing regime, starting from day 5 through to day 2, was used to preserve the overall significance level. This is the day 3 secondary endpoint.
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End point type |
Secondary
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End point timeframe |
Corneometry readings for this endpoint were obtained on the first measurement in the morning (around 9 am) of days 1 (baseline) and 3; before the first morning application on the day.
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| Notes [13] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. [14] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. |
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Statistical analysis title |
Treatment effect DELP Gel vs ZBC | ||||||||||||
Statistical analysis description |
This secondary endpoint was analysed using a mixed model taking into account the within-patient design, with patient as a random effect and leg, randomised group and treatment as fixed effects and with baseline corneometry measurement as a covariate. The number of patients included in each analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis.
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Comparison groups |
DELP Gel treated legs v ZBC treated legs
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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 [15] | ||||||||||||
P-value |
< 0.0001 [16] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
11
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
7 | ||||||||||||
upper limit |
15 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.88
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| Notes [15] - The number of patients included in this analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). Parameter estimate is least squares mean treatment difference for the change from baseline to the first corneometry reading on day 3. [16] - A hierarchical testing regime was used, starting from day 5 through to day 2, to preserve the overall significance level (significant at 5% level, 2-sided). |
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End point title |
DELP Gel vs ZBC: Change from baseline to first corneometry measurement on day 2 | ||||||||||||
End point description |
Secondary endpoints were the comparison between DELP Gel and ZBC in the change from baseline to the first corneometry measurement obtained on each of days 2 to 5. Since this is actually four secondary endpoints, a hierarchical testing regime, starting from day 5 through to day 2, was used to preserve the overall significance level. This is the day 2 secondary endpoint.
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End point type |
Secondary
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End point timeframe |
Corneometry readings for this endpoint were obtained on the first measurement in the morning (around 9 am) of days 1 (baseline) and 2; before the first morning application on the day.
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| Notes [17] - All 18 patients applied DELP Gel to one leg and ZBC to the other. 17 patients had data for day 2. [18] - All 18 patients applied DELP Gel to one leg and ZBC to the other. 17 patients had data for day 2. |
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Statistical analysis title |
Treatment effect DELP Gel vs ZBC | ||||||||||||
Statistical analysis description |
This secondary endpoint was analysed using a mixed model taking into account the within-patient design, with patient as a random effect and leg, randomised group and treatment as fixed effects and with baseline corneometry measurement as a covariate. The number of patients included in each analysis was 17 (not 34), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis.
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Comparison groups |
DELP Gel treated legs v ZBC treated legs
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority [19] | ||||||||||||
P-value |
< 0.0001 [20] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (net) | ||||||||||||
Point estimate |
9.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
5.6 | ||||||||||||
upper limit |
12.8 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.68
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| Notes [19] - The number of patients included in this analysis was 17 (not 34), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). Parameter estimate is least squares mean treatment difference for the change from baseline to the first corneometry reading on day 2. [20] - A hierarchical testing regime was used, starting from day 5 through to day 2, to preserve the overall significance level (significant at 5% level, 2-sided). |
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End point title |
Patient reported outcomes: overall product acceptance | |||||||||||||||
End point description |
Patients were asked to rate the overall acceptability of the treatments on their left and right legs on a five point scale (Dislike Strongly to Like Strongly). The overall acceptability endpoint was the proportion of patients ticking either ‘Like Strongly’ or ‘Like Slightly’ for DELP Gel vs. ZBC. Patients who ticked 'Dislike Strongly', 'Dislike Slightly' or 'Neither Like nor Dislike' are labelled as "Not ticked 'Like Strongly’ or ‘Like Slightly’" in the results presented below.
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End point type |
Secondary
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End point timeframe |
Questionnaire completed by the patients at the end of the 5 day treatment period.
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| Notes [21] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. [22] - Bilateral design - all 18 patients applied DELP Gel to one leg and ZBC to the other. |
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Statistical analysis title |
DELP Gel vs ZBC | |||||||||||||||
Statistical analysis description |
The secondary efficacy analysis variable of overall acceptability was the proportion of patients ticking either “Like Strongly” or “Like Slightly”. This was compared for the two study products, within subjects, using Prescott’s test which is similar to McNemar’s test but allows for an effect of leg.
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Comparison groups |
ZBC treated legs v DELP Gel treated legs
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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 [23] | |||||||||||||||
P-value |
= 0.61 | |||||||||||||||
Method |
Prescott's test | |||||||||||||||
Parameter type |
Risk difference (RD) | |||||||||||||||
Point estimate |
0.22
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-0.17 | |||||||||||||||
upper limit |
0.62 | |||||||||||||||
| Notes [23] - The number of patients included in each analysis was 18 (not 36), as this was a within-patient, bilateral comparison study (each patient received both treatments, one to each leg). The Full Analysis Set was used for this ITT analysis. |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were recorded throughout the five day treatment period. Any ongoing AEs were followed up until resolved, the condition stabilised, was otherwise explained, or the patient was lost to follow up.
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Adverse event reporting additional description |
No intrusive safety monitoring procedures were used due to the accepted safety profile of the products. All AEs were recorded in the adverse events section of the CRF. AEs recorded by the patient in the treatment diary were subsequently entered into the CRF.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
As reported in CRF | ||||||||||||||||||||||||||||||||||||
Dictionary version |
N/A
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Reporting groups
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Reporting group title |
All randomised patients
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Reporting group description |
The Safety Analysis Set comprised of all randomised patients who used at least one of the study products, this was actually all randomised patients. All safety analyses were based on the Safety Analysis Set. | ||||||||||||||||||||||||||||||||||||
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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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12 Jun 2015 |
A minor amendment of the protocol was implemented after the clinical phase of the study had been completed, to correct a typo in the sample size justification, and to clarify one of the secondary endpoints. This amendment did not materially change the protocol or statistical analysis, however it was deemed appropriate to manage it as substantial amendment given its relation to the scientific value of the study. Note that this minor amendment was instigated subsequent to the End of Trial notification, and so it was not formally acknowledged by the regulatory authority (date of letter, and implementation of amendment : 07/09/2016). |
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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 declared. | |||
