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

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ClinicalTrials.gov Identifier: NCT00644579
Recruitment Status : Unknown
Verified March 2008 by NatImmune A/S.
Recruitment status was:  Recruiting
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
NatImmune A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Warts Drug: bLAC Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : February 2009

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Arms and Interventions
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Arm Intervention/treatment
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
Placebo Comparator: 3 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Prospective ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Prospective ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644579


Contacts
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Contact: Claus Zachariae, MD, Chief Physician +4539773203 clza@geh.regionh.dk

Locations
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Denmark
Dermatology Clinic, Vesterbro Recruiting
Aalborg, Denmark, DK-9000
Principal Investigator: Henrik Sølvsten, MD         
Marselisborg University Hospital Recruiting
Aarhus C, Denmark, DK-8000
Principal Investigator: Mette S Deleuran, MD         
Bispebjerg University Hospital Recruiting
Copenhagen NV, Denmark, DK-2400
Principal Investigator: Merete Hædersdal, MD         
Gentoftte Amtssygehus Recruiting
Hellerup, Denmark, DK-2900
Principal Investigator: Claus Zachariae, MD         
Odense University Hospital Recruiting
Odense, Denmark, DK-5000
Principal Investigator: Henrik Lorentzen, MD         
Sponsors and Collaborators
NatImmune A/S
Investigators
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Principal Investigator: Claus Zachariae, MD Gentofte Amtssygehus
More Information
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Responsible Party: NatImmune A/S, NatImmune
ClinicalTrials.gov Identifier: NCT00644579    
Other Study ID Numbers: CL-1205
EudraCT number: 2007-006738-33
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008
Keywords provided by NatImmune A/S:
wart
cutaneous
transplant
Cutaneous warts in immune suppressed, kidney transplant patients
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
 Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases