Condition category
Skin and Connective Tissue Diseases
Date applied
01/03/2007
Date assigned
04/05/2007
Last edited
10/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Patrick Dupuy

ORCID ID

Contact details

Orfagen
Parc Technologique du canal
4 rue Marie Curie
BP 22132
Ramonville St Agne
31521
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V00034 CR 308 (ORF)

Study information

Scientific title

Acronym

Study hypothesis

Primary objective:
To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.

Secondary objectives:
1. To assess the local tolerance of V0034 CR 01B after long-term use
2. To assess the patient benefit and acceptability of V0034 CR 01B

Please note that as of the 18th January 2008 this record was updated. Changes are written under the relevant sections under the date 18/01/2008. Please also note that the anticipated end date of this trial has been extended to 30/09/2008. The previous anticipated end date of this trial was 30/09/2007. Please also note that the following countries of recruitment have been added to this record as of 18/01/2008: Hungary, Czech Republic, Latvia.

Ethics approval

Approval from:
1. Comités de Protection des Personnes, Sud Méditerranée IV, Hôpital St Eloi (France), approved on 25th August 2006
2. Sächsische Landesärztekammer Ethics Committee (Germany), approved on 14th November 2006
3. Commission of bioethics at Wroclaw Medical University (Poland), approved on 30th September 2006
4. Center of Katerini, General Hospital of Katerini (Greece), approved on 20th October 2006
5. Center of Szeged, University of Szeged (Hungary), approval pending
6. Center of Praha, Charles University School of Medicine (Czech Republic), approval pending
7. Center of Riga, Latvian Dermatology Institute Ltd Clinic (Latvia), approval pending

Study design

Periods I + II: randomised, double blind, parallel group study; period III: open-labelled, non-controlled, one-arm study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Uraemic xerosis

Intervention

The study will comprise three periods:
Period I: randomised, vehicle-controlled, double-blind, two-parallel group, comparative study (initial treatment period) - once daily application of V0034 CR 01B or its vehicle
Period II: randomised, double blind, two-parallel group study (treatment-free follow-up) - no topical treatment
Period III : open-labelled, non-controlled, one arm study (maintenance treatment period) - V0034 CR 01B application at dosage ad libitum

Intervention type

Drug

Phase

Not Specified

Drug names

V0034 CR 01B cream

Primary outcome measures

1. Treatment response of xerosis on five test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined physician’s five-point severity scale (Gammal severity scale). Treatment response will be defined as a score of zero or one on all test areas at the end of Period I, and a reduction of at least two grades on at least one test area (primary efficacy parameter, Period I).
2. Time to relapse, as defined as the time up to which patients have at least one test area with a severity score of at least two during the treatment-free follow-up (Period II). Only patients with no persisting lesions on day 28 will be evaluated for this parameter.

Secondary outcome measures

1. Change from baseline of the Gammal severity score of the five test areas, as assessed by the physicians. Total severity score (sum of scores of the test areas) and separate scores by test area will be presented. Recurrence rate (i.e. proportion of patients with at least one test area with a score of at least two) will be accounted during Period III.
2. Scaling measurement (mean optical density of squames [MOD], total surface area of squames [SURFT]) on one lower leg made by the physician, using D-Squame
3. Assessment of the global severity of xerosis and pruritus made by the patients, using 10-cm Visual Analogue Scales (VAS)
4. Life quality assessment performed by 12-item Short Form health survey (SF-12) (generic scale) and Dermatology Life Quality Index (DLQI) scales, made by the patients
5. Global agreement of the test product by the patients on efficacy and ease of use, using a four-point scale (very satisfactory to not satisfactory at all)

Overall trial start date

18/12/2006

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of both sexes, of at least 18 years of age
2. Women of childbearing potential having a reliable contraceptive method
3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
4. Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
5. Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240 patients

Participant exclusion criteria

1. Patients under 18 years of age
2. Women with childbearing potential having a positive pregnancy test at baseline
3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency
4. Patients whose xerosis is due to another reason than their MRD status
5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
6. Patients with a known history of allergy to one of the ingredients contained in the test product
7. Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
8. Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
9. Patients who participated in a study within the three months prior to study entry
10. Patients who are not affiliated to health insurance
11. Patients who are not able or willing to follow the study instructions

Recruitment start date

18/12/2006

Recruitment end date

30/09/2008

Locations

Countries of recruitment

Czech Republic, France, Germany, Greece, Hungary, Latvia, Poland

Trial participating centre

Orfagen
Ramonville St Agne
31521
France

Sponsor information

Organisation

Orfagen (France)

Sponsor details

Parc Technologique du canal
4 rue Marie Curie
BP 22132
Ramonville St Agne
31521
France

Sponsor type

Industry

Website

http://www.orfagen.com/homepage/0,7134,20877876_0_0_fr_FR_0,00.html?vid=20878546

Funders

Funder type

Industry

Funder name

Orfagen (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes