WartsPhase 2NCT01757392
Candin Safety & Efficacy Study for the Treatment of Warts
A Phase 2 study testing Candida albicans Skin Test Antigen in people with Warts and Human Papilloma Virus, run by Nielsen BioSciences, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Warts, Human Papilloma Virus
- What is being tested?
- Candida albicans Skin Test Antigen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have at least 3 and not more than 10 common warts not located on the palms or digits
- Positive DTH response to Candin® required
Who cannot join
- No previous medical treatment for warts other than OTC
- No immunocompromising medical conditions or medicines allowed
- No preexisting inflammatory conditions at treatment site allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).
Read the detailed description
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.
- Conditions
- Warts, Human Papilloma Virus
- Being tested
- Candida albicans Skin Test Antigen
- Keywords
- Treatment, common wart lesions, (verruca vulgaris)
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida albicans Skin Test AntigenBiological
Also called Candin®
0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
| Study group | Role | What they receive |
|---|---|---|
| Candin® 0.3 mL | Experimental | Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections. Receives: Biological: Candida albicans Skin Test Antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Resolution of Primary Injected Wart
Measured: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Secondary outcomes (1)
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
Measured: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandy M Johnson, MD, Principal investigator, Johnson Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757392
- Sponsor's protocol ID
- Nieslen Protocol CFW-2c
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2012
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
- ClinicalTrials.gov ID
- NCT01757392
- Acronym / sponsor ID
- Nieslen Protocol CFW-2c
- Conditions
- Warts, Human Papilloma Virus
- Keywords
- Treatment, common wart lesions, (verruca vulgaris)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Nielsen BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).
Detailed description
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candin® 0.3 mL | Experimental | Biological: Candida albicans Skin Test AntigenMonthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have at least 3 and not more than 10 common warts not located on the palms or digits
- Positive DTH response to Candin® required
Key exclusion criteria (3 listed)
- No previous medical treatment for warts other than OTC
- No immunocompromising medical conditions or medicines allowed
- No preexisting inflammatory conditions at treatment site allowed
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 |
|---|---|---|
| Candida albicans Skin Test AntigenAlso: Candin®0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections. | Biological | Candin® 0.3 mL |
Primary outcome
Number of Participants With Complete Resolution of Primary Injected Wart
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
1 secondary outcome
Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits
Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Warts
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
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.
Sandy M Johnson, MD principal investigator
Johnson Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candida albicans Skin Test Antigen in people with Warts and Human Papilloma Virus, run by Nielsen BioSciences, Inc. at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Resolution of Primary Injected Wart (time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months). 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 4 Feb 2021.