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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Patients with cutaneous warts located on fingers and/or palms and/or toes
and/or soles of the feet.
2. Index Wart lesions include: common warts (verruca vulgaris) and mosaic
warts. Index warts lesions must be diagnosed by an experienced dermatologist
on clinical basis.
3. Patients with a solitary wart lesion with a diameter of at least 1 cm2, or patients
with 2 or more wart lesions, the minimum area of each of the selected index
wart lesions is 0.5 cm². (A maximum of eight lesions is selected for treatment
and the maximum of total index lesion area = 9 cm²).
4. Index wart lesions should have been present for more than 6 months.
5. Men or women, aged 18 or above.
6. All patients should have a history of a kidney transplantation and immune
suppressive therapy after the transplant.
7. Concomitant immune suppressive therapy should have been stable for 6
monthsprior to randomisation, defined as no changes in number of drugs used,
but a change in doses for the individual immune suppressive drugs of ± 50 % is
allowed in the 6 months prior to randomisation
8. Agreement from the patient to allow photographs of the selected warts to be
taken and used as part of the trial data documentation (2 centres).
9. Women of childbearing potential must have a negative pregnancy test at
screening and must use adequate contraception (pill, contraceptive implant,
intrauterine device) during the trial.
10. Ability to comply with the requirements of the trial.
11. Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Verruca plana lesions.
2. Patients suspected of allergy to milk verified by serum analysis of IgG towards
cow milk.
3. Breastfeeding patients.
4. Any local medications for any purpose other than wart treatment in the target
area during 4 weeks prior to randomisation and during the treatment period
(weeks 0-8).
5. Concomitant treatment with other wart therapies two weeks prior to
randomisation in the present trial and during the clinical trial period.
6. Intolerance towards bovine a-lactalbumin, oleic acid, or any excipient in the bLAC
formulation.
7. Known HIV infection or any current uncontrolled infection.
8. Any chronic or acute skin condition susceptible of interfering with the evaluation
of the drug effect in this trial.
9. Participation in any investigational trial or use of any investigational drug within
30 days prior to inclusion in this trial.
10. Any health problems, which according to the Investigator’s clinical judgment will
make the patient unsuitable for inclusion in the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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