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Clinical Trial Results:
RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS.

Summary
EudraCT number	2005-002803-18
Trial protocol	FR FI EE LV DE
Global end of trial date	22 Jun 2006

Results information
Results version number	v2(current)
This version publication date	11 May 2019
First version publication date	21 Nov 2018
Other versions	v1
Version creation reason	Correction of full data set Add full data set

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

V00034CR3041B

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Pierre Fabre Médicament

Sponsor organisation address

45, Place Abel Gance, Boulogne, France, 92100

Public contact

Alain DELARUE, M.D, Institut de recherche Pierre Fabre, +33 5.61.73.73.09, alain.delarue@pierre-fabre.com

Scientific contact

Alain DELARUE, M.D, Institut de recherche Pierre Fabre, +33 5.61.73.73.09, alain.delarue@pierre-fabre.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

25 Sep 2006

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Jun 2006

Global end of trial reached?

Yes

Global end of trial date

22 Jun 2006

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the short term efficacy of the emollient V0034CR in addition to a moderately potent topical corticosteroid in the acute phase of treatment of atopic dermatitis, by reducing the disease severity.

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. An information letter was given to the parent(s) or guardian(s) of each patient to assist them with their decision. Parent(s) or guardian(s) signed a written consent form, which described the details and constraints of the study, as well as the right to withdraw at any point, anonymity, and the right to access the data. The parent(s) or guardian(s), the investigator each had a copy of the signed consent form, as well as the sponsor for which it was sealed in an envelope to maintain confidentiality.

Background therapy

Corticosteroid treatment was used by the parents on the lesions 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 (one 250 mL bottle for 3 weeks; batch F727; expiry date: 10/2007). Way of life and cosmetic cares should not be changed. Food supplements that could modify the skin properties as well as swimming pool were not allowed.

Evidence for comparator

Due to the natural evolution of the disease, the parallel groups design was the only one adapted to the study purpose. Very few emollients have been evaluated double blind, thus contributing to the lack of proofs of their efficacy. In order to evaluate the benefit of the emollient V0034CR, placebo was mandatory and justified. Furthermore, the use of a placebo was ethically acceptable since all patients received an active treatment by corticosteroids for treating inflammatory signs.

Actual start date of recruitment

19 Nov 2005

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country