Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by NatImmune A/S.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NatImmune A/S
ClinicalTrials.gov Identifier:
NCT00644579
First received: March 25, 2008
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Cutaneous Warts
Drug: bLAC
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by NatImmune A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644579

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

Locations
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
Principal Investigator: Claus Zachariae, MD Gentofte Amtssygehus
  More Information

No publications provided

Responsible Party: NatImmune A/S, NatImmune
ClinicalTrials.gov Identifier: NCT00644579     History of Changes
Other Study ID Numbers: CL-1205, EudraCT number: 2007-006738-33
Study First Received: March 25, 2008
Last Updated: March 26, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by NatImmune A/S:
wart
cutaneous
transplant
Cutaneous warts in immune suppressed, kidney transplant patients

Additional relevant MeSH terms:
Warts
DNA Virus Infections
Neoplasms
Papillomavirus Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014