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

Cutaneous Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00644579
• Other study ID #: CL-1205
• Secondary ID: EudraCT number:
• Status: Recruiting
• Phase: Phase 2
• First received: March 25, 2008
• Last updated: March 26, 2008
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2008
• Source: NatImmune A/S
• Contact: Claus Zachariae, MD, Chief Physician
• Phone: +4539773203
• Email: clza[@]geh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Warts
• Warts

Intervention

Drug:
• bLAC
bLAC high and low dose and placebo
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
NatImmune A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No