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

Sponsored by:	NatImmune A/S
Information provided by:	NatImmune A/S
ClinicalTrials.gov Identifier:	NCT00644579

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 II

MedlinePlus related topics: Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

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
1: Active Comparator bLAC high dose	Drug: bLAC bLAC high and low dose and placebo
2: Active Comparator bLAC low dose	Drug: bLAC bLAC high and low dose and placebo
3: Placebo Comparator	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

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

Sponsors and Collaborators

NatImmune A/S

Investigators

Principal Investigator:

Claus Zachariae, MD

Gentofte Amtssygehus

More Information

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

Keywords provided by NatImmune A/S:

wart
cutaneous
transplant
Cutaneous warts in immune suppressed, kidney transplant patients

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Warts

Skin Diseases
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009