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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cutaneous Warts

Intervention / Treatment
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* Drug: bLAC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>bLAC high dose | Drug: bLAC<br>* bLAC high and low dose and placebo<br>|
| Active Comparator: 2<br>bLAC low dose | Drug: bLAC<br>* bLAC high and low dose and placebo<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wart, cutaneous, transplant, Cutaneous warts in immune suppressed, kidney transplant patients