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

NatImmune

Status and phase: Unknown; Phase 2

Conditions: Cutaneous Warts

Treatments: Drug: bLAC; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644579

EudraCT number: 2007-006738-33

CL-1205

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

bLAC high dose

Treatment:

Drug: bLAC

2

Active Comparator group

Description:

bLAC low dose

Treatment:

Drug: bLAC

3

Placebo Comparator group

Treatment:

Drug: Placebo