bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
NCT ID: NCT00644579
Last Updated: 2008-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2008-03-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
bLAC high dose
bLAC
bLAC high and low dose and placebo
2
bLAC low dose
bLAC
bLAC high and low dose and placebo
3
Placebo
Placebo
Interventions
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bLAC
bLAC high and low dose and placebo
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NatImmune A/S
INDUSTRY
Responsible Party
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NatImmune
Principal Investigators
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Claus Zachariae, MD
Role: PRINCIPAL_INVESTIGATOR
Gentofte Amtssygehus
Locations
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Dermatology Clinic, Vesterbro
Aalborg, , Denmark
Marselisborg University Hospital
Aarhus C, , Denmark
Bispebjerg University Hospital
Copenhagen NV, , Denmark
Gentoftte Amtssygehus
Hellerup, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Other Identifiers
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EudraCT number: 2007-006738-33
Identifier Type: -
Identifier Source: secondary_id
CL-1205
Identifier Type: -
Identifier Source: org_study_id