bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients

bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients

As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients.

Study Overview

• Status: Unknown
• Conditions: Cutaneous Warts
• Intervention / Treatment: Drug: Placebo; Drug: bLAC

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, DK-9000
    • Recruiting
    • Dermatology Clinic, Vesterbro
    • Principal Investigator: Henrik Sølvsten, MD
  • Aarhus C, Denmark, DK-8000
    • Recruiting
    • Marselisborg University Hospital
    • Principal Investigator: Mette S Deleuran, MD
  • Copenhagen NV, Denmark, DK-2400
    • Recruiting
    • Bispebjerg University Hospital
    • Principal Investigator: Merete Hædersdal, MD
  • Hellerup, Denmark, DK-2900
    • Recruiting
    • Gentoftte Amtssygehus
    • Principal Investigator: Claus Zachariae, MD
  • Odense, Denmark, DK-5000
    • Recruiting
    • Odense University Hospital
    • Principal Investigator: Henrik Lorentzen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cutaneous warts on ingers and/or palms and/or toes and/or soles of feet
• Common warts and mosaic warts, diagnosed by an experienced dermatologist
• Solitary wart lesions or 2 or more lesions per patient
• Lesions present for more than 6 months
• Men or women, aged 18 or above
• History of kidney transplantation and immune suppressive therapy after transplant
• Concomitant immune suppressive therapy stable for 6 months prior to randomization
• Agreement from patient to allow photographs to be taken and used as part of trial data documentation (2 centres)
• Women of childbearing potential must have negative pregnancy test at screening and must use adequate contraception
• Ability to comply with requirements of trial
• Written informed consent

Exclusion Criteria:

• Verruca plana lesions
• Suspected allergy to milk verified by serum analysis of IgE towards cow milk
• Breastfeeding
• Any local medication for any purpose other than wart treatment in target area during 4 weeks prior to randomization and during treatment period
• Concomitant treatment with other wart therapies two weeks prior to randomization and during trial period
• Intolerance towards bovine alpha-lactalbumin, oleic acid or any excipient in the formulation
• Known HIV infection or any current uncontrolled infection
• Any chronic or acute skin condition susceptible of interfering with evaluation of drug effect in this trial
• Participation in any investigational trial or use of any investigational drug within 30 days prior to inclusion in this trial
• Any health problems which according to Investigator's clinical judgment will make the patient unsuitable for inclusion in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3	Drug: Placebo; Placebo
Active Comparator: 1; bLAC high dose	Drug: bLAC; bLAC high and low dose and placebo
Active Comparator: 2; bLAC low dose	Drug: bLAC; bLAC high and low dose and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the area of wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, measured by an objective method by drawing of individual lesions	Prospective

Secondary Outcome Measures

Outcome Measure	Time Frame
Clearance of index wart lesions. Time to clearance of warts. Recurrence rate of previously cleared wart lesions. Occurrence of new warts.overall changes of index warts lesions. Safety and tolerability.	Prospective

Collaborators and Investigators

• Sponsor: NatImmune A/S
• Investigators: Principal Investigator: Claus Zachariae, MD, Gentofte Amtssygehus

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Estimate): March 27, 2008
• Last Update Submitted That Met QC Criteria: March 26, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: transplant; wart; cutaneous; Cutaneous warts in immune suppressed, kidney transplant patients
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: CL-1205; EudraCT number: 2007-006738-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No