Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

NCT ID: NCT01084148

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-03-31

Brief Summary

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

Conditions

Uremic Xerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

V0034CR01B

cream

Group Type: EXPERIMENTAL

V0034CR01B

Intervention Type: DRUG

V0034 CR 01B vehicle

cream

Group Type: PLACEBO_COMPARATOR

V0034CR01B vehicle

Intervention Type: DRUG

Interventions

V0034CR01B

Intervention Type: DRUG

V0034CR01B vehicle

Intervention Type: DRUG

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orfagen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Szepietowski JC, Kemeny L, Mettang T, Arenberger P. Long-Term Efficacy and Tolerability of an Emollient Containing Glycerol and Paraffin for Moderate-to-Severe Uremic Xerosis: A Randomized Phase 3 Study. Dermatol Ther (Heidelb). 2024 Nov;14(11):3033-3046. doi: 10.1007/s13555-024-01287-w. Epub 2024 Oct 18.

Reference Type: DERIVED

PMID: 39422853 (View on PubMed)

Other Identifiers

V00034 CR 308 ORF

Identifier Type: -

Identifier Source: org_study_id