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

NCT01084148 | Completed Phase 3 Results

• 1 other identifier: V00034 CR 308 ORF
• Study Type: interventional
• Target: 237
• Locations: 0 countries
• Sites: N/A

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

Conditions

Uremic Xerosis

Outcome Measures

Primary Outcomes (1)

• Treatment Response of Xerosis

  Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin 1. = patches of fine, powdery scales 2. = diffuse ashy appearance with many fine scales 3. = moderate scaling with beginning cracks 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).

  28 days

Secondary Outcomes (1)

• Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B

  133 days

Study Arms (2)

V0034CR01B

EXPERIMENTAL

cream

Drug: V0034CR01B

V0034 CR 01B vehicle

PLACEBO COMPARATOR

cream

Drug: V0034CR01B vehicle

Interventions

V0034CR01B DRUG

V0034CR01B

V0034CR01B vehicle DRUG

V0034 CR 01B vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes, of at least 18 years of age
• Women of childbearing potential having a reliable contraceptive method
• Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
• Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Orfagen: lead

Related Publications (1)

• 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.

  PMID: 39422853 DERIVED

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Orfagen

caroline.miklaszewski@orfagen.com

0033 5 34 50 64 62

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 10, 2010
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 20, 2017
• Results First Posted: March 18, 2014

Record last verified: 2017-11