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

Primary Purpose

Cutaneous Warts

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
bLAC
Placebo
Sponsored by
NatImmune A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Warts focused on measuring wart, cutaneous, transplant, Cutaneous warts in immune suppressed, kidney transplant patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatology Clinic, VesterbroRecruiting
  • Marselisborg University HospitalRecruiting
  • Bispebjerg University HospitalRecruiting
  • Gentoftte AmtssygehusRecruiting
  • Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

bLAC high dose

bLAC low dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 25, 2008
Last Updated
March 26, 2008
Sponsor
NatImmune A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00644579
Brief Title
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NatImmune A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Warts
Keywords
wart, cutaneous, transplant, Cutaneous warts in immune suppressed, kidney transplant patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
bLAC high dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
bLAC low dose
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bLAC
Intervention Description
bLAC high and low dose and placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
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.
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claus Zachariae, MD, Chief Physician
Phone
+4539773203
Email
clza@geh.regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Zachariae, MD
Organizational Affiliation
Gentofte Amtssygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Clinic, Vesterbro
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Sølvsten, MD
Facility Name
Marselisborg University Hospital
City
Aarhus C
ZIP/Postal Code
DK-8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette S Deleuran, MD
Facility Name
Bispebjerg University Hospital
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal, MD
Facility Name
Gentoftte Amtssygehus
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Zachariae, MD
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Lorentzen, MD

12. IPD Sharing Statement

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

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