Clinical trial NCT00644579: bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cutaneous Warts
Keywords: wart
cutaneous
transplant
Cutaneous warts in immune suppressed, kidney transplant patients
Lead sponsor: NatImmune A/S
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Prospective
Secondary outcomes:
measure: 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.
timeFrame: Prospective
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dermatology Clinic, Vesterbro
city: Aarhus C
country: Denmark
facility: Marselisborg University Hospital
city: Copenhagen NV
country: Denmark
facility: Bispebjerg University Hospital
city: Hellerup
country: Denmark
facility: Gentoftte Amtssygehus
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Gentofte Amtssygehus
name: Claus Zachariae, MD
role: PRINCIPAL_INVESTIGATOR
References: