Clinical Trial Results:
A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCort 1% cream versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCort 1% cream
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Summary
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EudraCT number |
2013-000715-25 |
Trial protocol |
DE |
Global end of trial date |
26 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Sep 2016
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First version publication date |
09 Sep 2016
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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 |
6520-9170-07
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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 |
MEDICE Arzneimittel Pütter GmbH & Co. KG
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Sponsor organisation address |
Kuhloweg 37, Iserlohn, Germany, 58638
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Public contact |
Medical Department, MEDICE Arzneimittel Pütter GmbH & Co. KG, +49 023719370, info@medice.de
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Scientific contact |
Medical Department, MEDICE Arzneimittel Pütter GmbH & Co. KG, +49 023719370, info@medice.de
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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 |
26 Nov 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Nov 2013
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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 |
To assess the superiority of Soventol HydroCort 1% cream versus vehicle and to assess safety of Soventol HydroCort 1% cream
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Protection of trial subjects |
A specific treatment was to be discontinued if a treatment area showed worsening effects after one week of treatment. Since the appearance of the skin disease was described by several criteria (edema/papulation, oozing/crusts, excoriations, scaling and lichenification) discontinuation of special test areas were to be determined at the discretion of the investigator
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Aug 2013
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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: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
45
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
The participants were selected via advertisements and from the patient pool of the 4 selected trial centers. | |||||||||
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Pre-assignment
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Screening details |
50 patients were enrolled in this clinical trial and were with normal trial completion. There were no dropouts. For this trial, a total of 51 patients were screened (1 screening failure) of which 50 patients were randomized. | |||||||||
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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 |
Investigator, Monitor, Data analyst, Carer, Assessor, Subject | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Soventol HydroCort 1% Cream | |||||||||
Arm description |
1% Hydrocortisone Cream | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
1% Hydrocortisone
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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 |
Cutaneous use
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Dosage and administration details |
Up to 3 FTUs corresponding to approximately 1.5 g of the IMPs Soventol HydroCort 1 % cream and the active ingredient-free vehicle were applied to the respective treatment areas three times daily (morning, noon and evening) over a 2-week treatment period by the patient. The applied IMPs were distributed equally in the test areas using finger stalls. The time between the 2 applications should have included minimum 3 hours and maximum 18 hours. The application times were documented in the patient diaries. On trial Day 1 the application of the IMPs was demonstrated to the patient at the trial center. The first treatment (Day 1) as well as one treatment on Days 4 and 8, each were carried out at the trial center.
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Arm title
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Placebo | |||||||||
Arm description |
Active ingrediant free vehicle to IMP | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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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 |
Cutaneous use
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Dosage and administration details |
Up to 3 FTUs corresponding to approximately 1.5 g of the IMPs Soventol HydroCort 1 % cream and the active ingredient-free vehicle were applied to the respective treatment areas three times daily (morning, noon and evening) over a 2-week treatment period by the patient. The applied IMPs were distributed equally in the test areas using finger stalls. The time between the 2 applications should have included minimum 3 hours and maximum 18 hours. The application times were documented in the patient diaries. On trial Day 1 the application of the IMPs was demonstrated to the patient at the trial center. The first treatment (Day 1) as well as one treatment on Days 4 and 8, each were carried out at the trial center.
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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 |
Safety set (SES)
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The SES comprised of all patients who received any IMP at least once. All safety analyses were based on the SES.
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Subject analysis set title |
Full analysis set (FAS)
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The FAS included all randomized patients who received at least one dose of IMP, and had at least one post-baseline assessment. The ITT analysis was based on the FAS.
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Subject analysis set title |
Valid case set (VSC)
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The VCS included all patients of the FAS without any major protocol deviation.
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End points reporting groups
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Reporting group title |
Soventol HydroCort 1% Cream
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Reporting group description |
1% Hydrocortisone Cream | ||
Reporting group title |
Placebo
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Reporting group description |
Active ingrediant free vehicle to IMP | ||
Subject analysis set title |
Safety set (SES)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The SES comprised of all patients who received any IMP at least once. All safety analyses were based on the SES.
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Subject analysis set title |
Full analysis set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The FAS included all randomized patients who received at least one dose of IMP, and had at least one post-baseline assessment. The ITT analysis was based on the FAS.
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Subject analysis set title |
Valid case set (VSC)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The VCS included all patients of the FAS without any major protocol deviation.
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End point title |
Erythema Scores - AUC comparison (Full analysis set) | ||||||||||||
End point description |
The primary aim of superiority of IMP vs. the vehicle to IMP was evaluated with respect to the area under the time curve (AUC) of baseline corrected erythema scores determined applying the linear trapezoidal rule over the whole experimental phase. Treatment success resulted in a decrease in erythema score, corresponding to a negative baseline corrected AUC.
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End point type |
Primary
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End point timeframe |
The severity of the lesions was clinically assessed by the investigator on Days 1, 4, 8 and 15
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Statistical analysis title |
Erythema Scores - AUC comperison (FAS) | ||||||||||||
Statistical analysis description |
The superiority of Soventol 1% vs. Placebo with respect to the AUC of baseline corrected erythema scores was assessed by testing the Hypothesis H0 against the alternative H1 applying the two-sided paired t-test with a type I error of 5 %.
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Comparison groups |
Placebo v Soventol HydroCort 1% Cream
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
= 0.0002 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-5.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-8.2 | ||||||||||||
upper limit |
-2.8 | ||||||||||||
| Notes [1] - If the obtained p-value was less than 0.05 and the mean AUC for IMP was less than the mean AUC for the vehicle to IMP, then the superiority of the IMP vs. vehicle was established. |
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End point title |
Erythema Scores - AUC comparison (Valid case set) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The severity of the lesions was clinically assessed by the investigator on Days 1, 4, 8 and 15
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Statistical analysis title |
Erythema Scores - AUC comparison (VCS) | ||||||||||||
Comparison groups |
Soventol HydroCort 1% Cream v Placebo
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Number of subjects included in analysis |
98
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.0002 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-5.6
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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 |
-2.9 | ||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs were recorded throughout the entire trial
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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 |
16.1
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Reporting groups
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Reporting group title |
all subjects
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Reporting group description |
Non-serious TEAEs were reported in 4 patients which were not corresponding to a specific test field. | ||||||||||||||||||||||||||||||||||||||||||||
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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? 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 | |||
