Status:
UNKNOWN
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
Lead Sponsor:
NatImmune A/S
Conditions:
Cutaneous Warts
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 benefic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00644579
Start Date
March 1 2008
End Date
February 1 2009
Last Update
March 27 2008
Active Locations (5)
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1
Dermatology Clinic, Vesterbro
Aalborg, Denmark, DK-9000
2
Marselisborg University Hospital
Aarhus C, Denmark, DK-8000
3
Bispebjerg University Hospital
Copenhagen NV, Denmark, DK-2400
4
Gentoftte Amtssygehus
Hellerup, Denmark, DK-2900