Clinical Trial Results:
LONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR. A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS, DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN
Summary
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EudraCT number |
2005-003396-21 |
Trial protocol |
FR EE FI LV DE |
Global end of trial date |
07 Nov 2006
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Results information
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Results version number |
v2(current) |
This version publication date |
11 May 2019
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First version publication date |
21 Nov 2018
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Other versions |
v1 |
Version creation reason |
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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 |
V00034CR3071B
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pierre Fabre Médicament
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Sponsor organisation address |
45, Place Abel Gance, Boulogne, France, 92100
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Public contact |
Alain DELARUE, M.D, INSTITUT DE RECHERCHE PIERRE FABRE
Innovation Développement Pierre Fabre
, +33 5.61.73.73.09, alain.delarue@pierre-fabre.com
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Scientific contact |
Alain DELARUE, M.D, INSTITUT DE RECHERCHE PIERRE FABRE
Innovation Développement Pierre Fabre
, +33 5.61.73.73.09, alain.delarue@pierre-fabre.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? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Sep 2006
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Sep 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Nov 2006
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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 evaluate the overall benefit of a regular treatment by the emollient V0034CR in the management of atopic dermatitis: reduction of corticosteroids consumption, reduction of flares
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Protection of trial subjects |
The study was conducted in accordance with the principles of the Declaration of Helsinki and subsequent amendments thereto, the Good Clinical Practices (CPMP/ICH/135/95) and local legal regulations.
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Background therapy |
Corticosteroid treatment was used by the parents on the lesions where they appeared, until complete resolution of the inflammatory signs, mainly the resolution of erythema. For their child's body and scalp washing, parents used the foaming gel Klorane* provided by the sponsor: bottle 250 mL; batch F727; expiry date: 10/2007 or bottle 500 mL; batch F742; expiry date: 12/2007. Way of life and cosmetic cares should not be changed. Food supplements that could modify the skin properties. Just after being in a swimming pool, emollient should be applied once more. | ||
Evidence for comparator |
Very few emollients have been evaluated double blind. In order to evaluate the effect of the emollient V0034 CR 01B, placebo was mandatory and justified. Furthermore, the use of a placebo (vehicle) was ethically acceptable since all patients received when necessary an active treatment by corticosteroids on one hand and because excipient topical formulations have also a well-known intrinsic activity that can improve the skin status. | ||
Actual start date of recruitment |
30 Nov 2005
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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 |
Estonia: 83
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Country: Number of subjects enrolled |
Finland: 20
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Country: Number of subjects enrolled |
France: 9
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Country: Number of subjects enrolled |
Germany: 22
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Country: Number of subjects enrolled |
Latvia: 81
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Country: Number of subjects enrolled |
Poland: 84
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Country: Number of subjects enrolled |
Romania: 29
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Worldwide total number of subjects |
328
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EEA total number of subjects |
328
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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) |
98
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Children (2-11 years) |
230
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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 |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Twenty two centres in 7 countries screened and treated 328 patients, male or female children, aged between 3 months and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party between the 30th of November 2005 and 07 September 2006. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Patients, male or female children, aged between 3 months and 7 years, presenting with atopic dermatitis according to the diagnostic criteria of the UK Working party, whose IGA score was < 1 at inclusion were screened. Patients in acute phase of AD or with a severe form of disease were excluded. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment period (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, Carer, Assessor | ||||||||||||||||||||||||
Blinding implementation details |
The study products as well as their packaging and labelling were rigorously identical. The investigator, the hospital pharmacist if appropriate, the study monitor had a set of blind sealed envelops corresponding to the treatments received and given to the patients. An envelope could be opened only in case of emergency (vital threatening, emergency) and only if the knowledge of the product having been received was necessary to start appropriate treatment.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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V0034CR arm | ||||||||||||||||||||||||
Arm description |
160 patients were randomised in the V0034CR arm | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
V0034 CR 01B cream
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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 |
Application in thin layers with a sufficient amount of cream, with a gentle massage until penetration, on the whole body (including face), morning and evening; when inflammatory lesions were present (disease exacerbation phases): application on the whole body (including face), in the evening. The study was long enough (6 months) to have flares during one winter/spring season and thus to register corticosteroid consumption. Corticosteroid treatment was applied by the parents only on the inflammatory lesions until complete resolution of the inflammatory signs (if applicable).
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Arm title
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Vehicle arm | ||||||||||||||||||||||||
Arm description |
168 patients were randomised in the vehicle arm | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Vehicle cream
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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 |
Application in thin layers with a sufficient amount of cream, with a gentle massage until penetration, on the whole body (including face), morning and evening; when inflammatory lesions were present (disease exacerbation phases): application on the whole body (including face), in the evening. The corticosteroid treatment was applied by the parents only on the inflammatory lesions until complete resolution of the inflammatory signs.
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Baseline characteristics reporting groups
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Reporting group title |
V0034CR arm
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Reporting group description |
160 patients were randomised in the V0034CR arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vehicle arm
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Reporting group description |
168 patients were randomised in the vehicle arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
V0034CR arm
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Reporting group description |
160 patients were randomised in the V0034CR arm | ||
Reporting group title |
Vehicle arm
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Reporting group description |
168 patients were randomised in the vehicle arm |
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End point title |
Number of days of application of corticosteroid. | ||||||||||||
End point description |
The main criterion was the number of days of application of corticosteroid (percentage of the total number of days in the study). To take into account not only dropouts but also different durations in the study for completers, this number of days was expressed as a percentage of the total number of days in the study.
This percentage was compared between treatment groups using Cochran-Mantel-Haenszel (CMH) with modified ridit scores, adjusting for centre.
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End point type |
Primary
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End point timeframe |
The number of days of application of corticosteroid was measured between the first visit of the study until the final visit (week 24)
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Statistical analysis title |
Primary analysis | ||||||||||||
Statistical analysis description |
The main criteria (number of days of application of a moderately potent corticosteroids used for treating flares) was compared between treatment groups using Cochran-Mantel-Haenszel test (row mean scores) adjusting for centre, using modified ridit scores to get an extension of the Wilcoxon rank sum test.
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Comparison groups |
V0034CR arm v Vehicle arm
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Number of subjects included in analysis |
328
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.429 | ||||||||||||
Method |
Mantel-Haenszel | ||||||||||||
Confidence interval |
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95% | ||||||||||||
sides |
2-sided
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lower limit |
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upper limit |
- |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were reported from the visit 2 (W4) until the final visit Visit 6 (W24).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
8.1
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Reporting groups
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Reporting group title |
V0034 CR arm
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Reporting group description |
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Reporting group title |
Vehicle arm
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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07 Sep 2005 |
Modification of the Subject information leaflet and consent form (French version), following the CCPPRB remarks (during the session of august 17, 2005) |
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29 Nov 2005 |
Modification of the dates of study schedule |
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29 Nov 2005 |
Precisions for some non inclusion criteria, conditions of use of Locapred and withdrawal conditions |
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20 Jan 2006 |
Modification of the dates of study schedule |
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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 |