Trial | NCT00644579  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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 Started
Mar 31
2008
Primary Completion
Dec 31
2008
Anticipated
Study Completion
Feb 28
2009
Anticipated
Last Update
Mar 27
2008
Estimate

Drug bLAC

bLAC high and low dose and placebo

Drug Placebo

Placebo

1 Active Comparator

bLAC high dose

2 Active Comparator

bLAC low dose

3 Placebo Comparator

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
No Results Posted