WartsPhase 2NCT02393417
Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
A Phase 2 study testing CANDIN in people with Warts, run by Nielsen BioSciences, Inc. at 15 sites in United States.
Trial summary
This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Warts
- What is being tested?
- CANDIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2015to Mar 2018
- 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
- Men or women between the ages of 18 and 65 years inclusively at time of consent
- Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit
- Subject's common warts for injection must measure between 3 and 20 mm at Baseline Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat, plantar, facial, periungual, genital warts or warts in region of pre-existing inflammatory condition are excluded from injection
- Subjects enrolled into Cohort 3 must have common warts for injection in at least 2 different anatomical regions defined as: left arm, right arm, left hand, right hand, left leg, right leg, left foot (excluding sole), right foot (excluding sole) and torso
- Subject, male or female is willing to use effective contraceptive method for at least 30 days before the Baseline Visit and at least 30 days after the last study drug administration unless not of childbearing potential as defined as post-menopausal for at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or hysterectomy for females, and vasectomy for males). The only contraceptive use exceptions would be individuals in exclusive same sex partnerships and individuals who agree to remain non-sexually active for the duration of the study. Acceptable contraceptive methods for subjects include:
- Barrier methods, such as condom, sponge or diaphragm, combined with spermicide in foam, gel or cream;
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- Hormonal contraception (oral, intramuscular, implant or transdermal which includes Depo-Provera, Evra and Nuvaring);
- Intrauterine device (IUD)
- Mentally and legally capable of giving informed consent prior to any study related procedures
Who cannot join
- Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function including psoriasis
- Subject has been diagnosed with diabetes mellitus
- Subject has a history of keloid formation
- Injectable common wart(s) located in areas with existing dermatologic conditions (such as psoriasis) or with an underlying inflammatory conditions (such as arthritic joints), or tattoos or implants/piercing/hardware or marking that may conceal responses or reactions are excluded from injection
- Existing/planned pregnancy, childbirth in the past six months prior to the Baseline Visit, or breast feeding, or plan on donating eggs or sperm during the study and in the month following the last injection
- Treatment of warts with liquid nitrogen, carbon dioxide, electrodessication, laser, surgery, simple occlusion (e.g. duct tape) salicylic or related acids, OTC treatments, cantharidin, or other treatments within 4 weeks of the Baseline Visit
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- Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment designed to stimulate immune response (except for treatments already listed in exclusion criterion 6) within 12 weeks of the Baseline Visit
- Recalcitrant warts defined as those not successfully treated by 5 or more treatments (excluding OTC treatments)
- Abnormal (low < 5 mm or high >25 mm) baseline result to the Delayed Type Hypersensitivity (DTH) test
- Subject has a condition or treatment resulting in being immunocompromised
- Systemic treatment (such as oral or injected) with cimetidine, zinc supplements at a dose higher than 20 mg of elemental zinc daily or an immunosuppressive drug (such as: azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids, etc.) within 12 weeks of the Baseline Visit
- Subject has used any investigational agent within 30 days prior to the Baseline Visit or within 5 half-lives of that investigational agent prior to the Baseline Visit (whichever is longer)
- Previous treatment of warts with any type of intralesional injection with candida extract (including CANDIN)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Austin Institute for Clinical Research Inc.
Austin, Texas, 78660
DermResearch Inc.
Austin, Texas, 78759
California Dermatology and Clinical Research Institute
Encinitas, California, 92024
Hamzavi Dermatology Clinical Trials
Fort Gratiot, Michigan, 48059
Johnson Dermatology
Fort Smith, Arkansas, 72916
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
Metro Boston Clinical Partners, LLC
Needham, Massachusetts, 02492
Silverberg MD Inc.
Newport Beach, California, 92660
Oregon Medical Research Center
Portland, Oregon, 97223
Northwest Arkansas Clinical Trials Center PLLC
Rogers, Arkansas, 72758
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
BayState Clinical Trials
Watertown, Massachusetts, 02472
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.
- Conditions
- Warts
- Being tested
- CANDIN, Placebo
- Keywords
- Verruca vulgaris, Common Warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANDINBiological
Candida albicans Skin Test Antigen for Cellular Hypersensitivity
PlaceboOther
0.9% Sodium Chloride Injection USP (non-preserved)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.3 mL of CANDIN administered intralesionally in the largest common wart Receives: Biological: CANDIN |
| Cohort 2 | Experimental | 0.5 mL of CANDIN administered intralesionally in the largest common wart Receives: Biological: CANDIN |
| Cohort 3 | Experimental | 0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Receives: Biological: CANDIN |
| Pooled Placebo | Placebo comparator | 0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Measured: 45 weeks
Secondary outcomes (8)
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Measured: 45 weeks
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Measured: 4 month follow up visit at 45 weeks
Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
Measured: 45 weeks
Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
Measured: 45 weeks
Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
Measured: 45 weeks
Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study
Measured: 45 weeks
Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
Measured: 45 weeks
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2018
- Study completionMar 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Carpenter, DVM, PhD, Study director, Nielsen BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393417
- Sponsor's protocol ID
- CFW-2D
- Status last verified
- May 2019
- First submitted
- 13 Mar 2015
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim KH, Horn TD, Pharis J, Kincannon J, Jones R, O'Bryan K, Myers J, Nakagawa M. Phase 1 clinical trial of intralesional injection of Candida antigen for the treatment of warts. Arch Dermatol. 2010 Dec;146(12):1431-3. doi: 10.1001/archdermatol.2010.350. No abstract available.
PubMed 21173332Smith SR, Esch RE, Nielsen HS, Johnson SM. Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens. Dermatol Ther (Heidelb). 2025 May;15(5):1135-1152. doi: 10.1007/s13555-025-01387-1. Epub 2025 Mar 29.
PubMed 40155509
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
- ClinicalTrials.gov ID
- NCT02393417
- Acronym / sponsor ID
- CFW-2D
- Conditions
- Warts
- Keywords
- Verruca vulgaris, Common Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Nielsen BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: CANDIN0.3 mL of CANDIN administered intralesionally in the largest common wart |
| Cohort 2 | Experimental | Biological: CANDIN0.5 mL of CANDIN administered intralesionally in the largest common wart |
| Cohort 3 | Experimental | Biological: CANDIN0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) |
| Pooled Placebo | Placebo comparator | Other: Placebo0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women between the ages of 18 and 65 years inclusively at time of consent
- Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit
- Subject's common warts for injection must measure between 3 and 20 mm at Baseline Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat, plantar, facial, periungual, genital warts or warts in region of pre-existing inflammatory condition are excluded from injection
- Subjects enrolled into Cohort 3 must have common warts for injection in at least 2 different anatomical regions defined as: left arm, right arm, left hand, right hand, left leg, right leg, left foot (excluding sole), right foot (excluding sole) and torso
- Subject, male or female is willing to use effective contraceptive method for at least 30 days before the Baseline Visit and at least 30 days after the last study drug administration unless not of childbearing potential as defined as post-menopausal for at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or hysterectomy for females, and vasectomy for males). The only contraceptive use exceptions would be individuals in exclusive same sex partnerships and individuals who agree to remain non-sexually active for the duration of the study. Acceptable contraceptive methods for subjects include:
Key exclusion criteria (13 listed)
- Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function including psoriasis
- Subject has been diagnosed with diabetes mellitus
- Subject has a history of keloid formation
- Injectable common wart(s) located in areas with existing dermatologic conditions (such as psoriasis) or with an underlying inflammatory conditions (such as arthritic joints), or tattoos or implants/piercing/hardware or marking that may conceal responses or reactions are excluded from injection
- Existing/planned pregnancy, childbirth in the past six months prior to the Baseline Visit, or breast feeding, or plan on donating eggs or sperm during the study and in the month following the last injection
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 |
|---|---|---|
| CANDINCandida albicans Skin Test Antigen for Cellular Hypersensitivity | Biological | Cohort 1, Cohort 2, Cohort 3 |
| Placebo0.9% Sodium Chloride Injection USP (non-preserved) | Other | Pooled Placebo |
Primary outcome
Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
Time frame: 45 weeks
Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart
8 secondary outcomes
Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
Time frame: 45 weeks
Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
Time frame: 4 month follow up visit at 45 weeks
Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
Time frame: 45 weeks
Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
Time frame: 45 weeks
Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
Time frame: 45 weeks
Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
Time frame: 45 weeks
Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
Time frame: 45 weeks
Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
Time frame: 45 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21173332Kim KH, Horn TD, Pharis J, Kincannon J, Jones R, O'Bryan K, Myers J, Nakagawa M. Phase 1 clinical trial of intralesional injection of Candida antigen for the treatment of warts. Arch Dermatol. 2010 Dec;146(12):1431-3. doi: 10.1001/archdermatol.2010.350. No abstract available.
- Derived from this study: PubMed 40155509Smith SR, Esch RE, Nielsen HS, Johnson SM. Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens. Dermatol Ther (Heidelb). 2025 May;15(5):1135-1152. doi: 10.1007/s13555-025-01387-1. Epub 2025 Mar 29.
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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.
Thomas Carpenter, DVM, PhD study director
Nielsen BioSciences, Inc.
15 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 CANDIN in people with Warts, run by Nielsen BioSciences, Inc. at 15 sites 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 9 inclusion and 13 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2019). 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 Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit (time frame: 45 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393417, which also lists 2 linked publications.
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 Jun 2019.