Cutaneous WartsPhase 2NCT00644579
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
A Phase 2 study testing bLAC in people with Cutaneous Warts, run by NatImmune A/S at 5 sites in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- bLAC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 5 sitesDenmark
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Dermatology Clinic, Vesterbro
Aalborg, DK-9000
Henrik Sølvsten, MD
- Recruiting
Marselisborg University Hospital
Aarhus C, DK-8000
Mette S Deleuran, MD
- Recruiting
Bispebjerg University Hospital
Copenhagen NV, DK-2400
Merete Hædersdal, MD
- Recruiting
Gentoftte Amtssygehus
Hellerup, DK-2900
Claus Zachariae, MD
- Recruiting
Odense University Hospital
Odense, DK-5000
Henrik Lorentzen, MD
About this study
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
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.
- Conditions
- Cutaneous Warts
- Being tested
- bLAC, Placebo
- Keywords
- wart, cutaneous, transplant, Cutaneous warts in immune suppressed, kidney transplant patients
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bLACDrug
bLAC high and low dose and placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | bLAC high dose Receives: Drug: bLAC |
| 2 | Active comparator | bLAC low dose Receives: Drug: bLAC |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2008 (estimated)
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NatImmune A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claus Zachariae, MD, Principal investigator, Gentofte Amtssygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644579
- Sponsor's protocol ID
- CL-1205
- Other IDs
- EudraCT number: 2007-006738-33
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00644579
- Acronym / sponsor ID
- CL-1205
- Conditions
- Cutaneous Warts
- Keywords
- wart, cutaneous, transplant, Cutaneous warts in immune suppressed, kidney transplant patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NatImmune A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: bLACbLAC high dose |
| 2 | Active comparator | Drug: bLACbLAC low dose |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bLACbLAC high and low dose and placebo | Drug | 1, 2 |
| PlaceboPlacebo | Drug | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Zachariae, MD principal investigator
Gentofte Amtssygehus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bLAC in people with Cutaneous Warts, run by NatImmune A/S at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claus Zachariae, MD, Chief Physician (+4539773203, clza@geh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2008.