NCT00644579

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

9 months

First QC Date

March 25, 2008

Last Update Submit

March 26, 2008

Conditions

Cutaneous Warts

Keywords

wartcutaneoustransplantCutaneous warts in immune suppressed, kidney transplant patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR

bLAC high dose

Drug: bLAC

2

ACTIVE COMPARATOR

bLAC low dose

Drug: bLAC

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

bLACDRUG

bLAC high and low dose and placebo

12
PlaceboDRUG

Placebo

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dermatology Clinic, Vesterbro

Aalborg, DK-9000, Denmark

RECRUITING

Marselisborg University Hospital

Aarhus C, DK-8000, Denmark

RECRUITING

Bispebjerg University Hospital

Copenhagen NV, DK-2400, Denmark

RECRUITING

Gentoftte Amtssygehus

Hellerup, DK-2900, Denmark

RECRUITING

Odense University Hospital

Odense, DK-5000, Denmark

RECRUITING

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Claus Zachariae, MD

    Gentofte Amtssygehus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus Zachariae, MD, Chief Physician

CONTACT

+4539773203clza@geh.regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 27, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

DK(5)