Long-term efficacy and safety of V0034 CR 01B cream in patients with moderate-to-severe uraemic xerosis

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN19139882
• Date of registration: 04/05/2007
• Prospective Registration: No
• Primary sponsor: Orfagen (France)
• Public title: Long-term efficacy and safety of V0034 CR 01B cream in patients with moderate-to-severe uraemic xerosis
• Date of first enrolment: 18/12/2006
• Target sample size: 240
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN19139882
• Study type: Interventional
• Study design: Periods I + II: randomised, double blind, parallel group study; period III: open-labelled, non-controlled, one-arm study (Treatment)

Countries of recruitment

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

Contacts

• Name: Patrick Dupuy

Key inclusion & exclusion criteria

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)
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Uraemic xerosis
Skin and Connective Tissue Diseases
Skin complaint associated with renal dialysis

Intervention(s)

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

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

V00034 CR 308 (ORF)

Source(s) of Monetary Support

Orfagen (France)