bLAC - Treatment of Cutaneous Warts in Immune Suppressed,... | NCT00644579

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

NCT00644579

Sponsor

NatImmune A/S

Status

Unknown status

Last Update Posted

Mar 27, 2008Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Cutaneous Warts

Interventions

bLAC
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT number: 2007-006738-33

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Feb 2009Estimated

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 26, 2008

First Posted Date

Mar 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2008

Last Update Posted Date

Mar 27, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	bLAC high dose	Drug: bLAC
2	Active Comparator	bLAC low dose	Drug: bLAC
3	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bLAC	Drug	bLAC high and low dose and placebo	1 2
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections