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
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