bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by NatImmune A/S.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
NatImmune A/S
Information provided by:
NatImmune A/S
ClinicalTrials.gov Identifier:
NCT00644579
First received: March 25, 2008
Last updated: March 26, 2008
Last verified: March 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous Warts |
Drug: bLAC Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by NatImmune A/S:
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 [ Time Frame: Prospective ] [ Designated as safety issue: No ]
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. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
bLAC high dose
|
Drug: bLAC
bLAC high and low dose and placebo
|
|
Active Comparator: 2
bLAC low dose
|
Drug: bLAC
bLAC high and low dose and placebo
|
| Placebo Comparator: 3 |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644579
Contacts
| Contact: Claus Zachariae, MD, Chief Physician | +4539773203 | clza@geh.regionh.dk |
Locations
| Denmark | |
| Dermatology Clinic, Vesterbro | Recruiting |
| Aalborg, Denmark, DK-9000 | |
| Principal Investigator: Henrik Sølvsten, MD | |
| Marselisborg University Hospital | Recruiting |
| Aarhus C, Denmark, DK-8000 | |
| Principal Investigator: Mette S Deleuran, MD | |
| Bispebjerg University Hospital | Recruiting |
| Copenhagen NV, Denmark, DK-2400 | |
| Principal Investigator: Merete Hædersdal, MD | |
| Gentoftte Amtssygehus | Recruiting |
| Hellerup, Denmark, DK-2900 | |
| Principal Investigator: Claus Zachariae, MD | |
| Odense University Hospital | Recruiting |
| Odense, Denmark, DK-5000 | |
| Principal Investigator: Henrik Lorentzen, MD | |
Sponsors and Collaborators
NatImmune A/S
Investigators
| Principal Investigator: | Claus Zachariae, MD | Gentofte Amtssygehus |
More Information
No publications provided
| Responsible Party: | NatImmune A/S, NatImmune |
| ClinicalTrials.gov Identifier: | NCT00644579 History of Changes |
| Other Study ID Numbers: | CL-1205, EudraCT number: 2007-006738-33 |
| Study First Received: | March 25, 2008 |
| Last Updated: | March 26, 2008 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by NatImmune A/S:
|
wart cutaneous transplant Cutaneous warts in immune suppressed, kidney transplant patients |
Additional relevant MeSH terms:
|
Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral |
Tumor Virus Infections Neoplasms Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013