Common Warts (Verruca Vulgaris)Phase 3NCT05889845
Candin for the Treatment of Common Warts
A Phase 3 study testing Candin, Intradermal Solution in people with Common Warts (Verruca Vulgaris), run by Nielsen BioSciences, Inc. at 18 sites in United States.
Trial summary
The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Common Warts (Verruca Vulgaris)
- What is being tested?
- Candin, Intradermal Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 18 sitesUnited States
- Study dates
- 22 Jan 2025to 27 Aug 2025
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 3, but not more than 20 common warts (Verruca vulgaris)
- Willing to agree to use adequate contraception methods during the study
Who cannot join
- Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function
- Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at the Baseline Visit
- History of keloid formation
- Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment
- Treatment with immunotherapy (e.g., diphenylcyclopropenone [DPCP], dinitrochlorobenzene [DNCB], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study
- Prior treatment with Candida albicans within 12 weeks of the Baseline Visit or during the study
- Systemic treatment with an immunosuppressive drug during the study or in the 6 months or 5 half lives prior to the Baseline Visit or during the study (e.g., azathioprine, 6 mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids [topical or inhaled steroids are acceptable]).
- Use of cantharidin or an investigational agent or device within the 30 days prior to the Baseline Visit or during the study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
DermResearch
Austin, Texas, 78759
Advocare Berlin Medical Associates
Berlin, New Jersey, 08009
Cahaba Dermatology
Birmingham, Alabama, 35244
Integrated Dermatology of Newton-Brighton
Brighton, Massachusetts, 02135
Arkansas Pediatric Clinic
Bryant, Arkansas, 72022
Kaminska Dermatology
Chicago, Illinois, 60657
Velocity Clinical Englewood
Englewood, Colorado, 80110
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Johnson Dermatology
Fort Smith, Arkansas, 72916
Velocity Clinical Hampton
Hampton, Virginia, 23666
Dermatology Clinic of Arkansas
Hot Springs, Arkansas, 71913
Velocity Clinical La Mesa
La Mesa, California, 91942
Long Beach Research
Long Beach, California, 90805
Bryn Mawr Health Center
Newtown Square, Pennsylvania, 19073
Schlessinger MD
Omaha, Nebraska, 68144
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Integrative Skin Research
Sacramento, California, 95815
Velocity Clinical Spartanburg
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin for the Treatment of Common Warts (Verruca Vulgaris) in Adolescents and Adults
The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:
- does treatment with Candin result in better clearance of warts than placebo
- how many injections are required to result in wart clearance Participants will
- have one wart selected for injection every two weeks until clearance
- return 12 weeks after wart clearance for assessment of durability of response
Read the detailed description
This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.
Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.
- Conditions
- Common Warts (Verruca Vulgaris)
- Being tested
- Candin, Intradermal Solution, Placebo
- Keywords
- Common wart, Intralesional injection, Candida albicans, Immunotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candin, Intradermal SolutionDrug
Injection at the base of the selected wart
PlaceboDrug
Injection at the base of the selected wart
| Study group | Role | What they receive |
|---|---|---|
| Candin treatment | Experimental | Candida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections Receives: Drug: Candin, Intradermal Solution |
| Placebo | Placebo comparator | Matching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete resolution of the treatment wart
Absence of visual or measurable wart maintained through the entire Observational Period for injected wart
Measured: Twelve weeks after last injection
Secondary outcomes (4)
Time to wart clearance
Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection.
Measured: Up to 27 weeks
Number of participants with clinical clearance of at least 50% of all measured warts
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Measured: Up to 27 weeks
Number of participants with clinical clearance of all measured warts
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Measured: Up to 27 weeks
Time to clinical clearance of all measured warts
The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.
Measured: Up to 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start22 Jan 2025
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Warts (Verruca Vulgaris)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889845
- Sponsor's protocol ID
- CFW-3A
- Status last verified
- Aug 2025
- First submitted
- 2 May 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Candin for the Treatment of Common Warts (Verruca Vulgaris) in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT05889845
- Acronym / sponsor ID
- CFW-3A
- Conditions
- Common Warts (Verruca Vulgaris)
- Keywords
- Common wart, Intralesional injection, Candida albicans, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Nielsen BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- 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.
The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are:
- does treatment with Candin result in better clearance of warts than placebo
- how many injections are required to result in wart clearance Participants will
- have one wart selected for injection every two weeks until clearance
- return 12 weeks after wart clearance for assessment of durability of response
Detailed description
This study involves a comparison of an equal volume injection of Candin with an injection of placebo (unpreserved normal saline solution) in common warts. Subjects will be randomized 2:1 to receive Candin or placebo. During the Treatment Period, 1 dose (0.5 mL) of investigational product (IP) will be injected every 2 weeks into a single treatment wart until either clinical clearance of the treatment wart is achieved or a total of 10 injections have been administered.
Subjects achieving clinical clearance of the treatment wart will receive a final injection at the site of the cleared wart and then immediately enter the Observational Period for 12 weeks. Complete resolution is achieved when a subject demonstrates clinical clearance for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Candin treatment | Experimental | Drug: Candin, Intradermal SolutionCandida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3, but not more than 20 common warts (Verruca vulgaris)
- Willing to agree to use adequate contraception methods during the study
Key exclusion criteria (8 listed)
- Systemic or localized diseases, conditions, or medications that could interfere with the assessment of safety or efficacy or that compromise immune function
- Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at the Baseline Visit
- History of keloid formation
- Prior treatment of common warts with liquid nitrogen, carbon dioxide, electrodesiccation, laser, surgery, salicylic acid, etc., that, in the Investigator's opinion, does not exhibit complete healing from the treatment
- Treatment with immunotherapy (e.g., diphenylcyclopropenone [DPCP], dinitrochlorobenzene [DNCB], or other), imiquimod, 5-fluorouracil, bleomycin, or podophyllin within 12 weeks of the Baseline Visit or during the study
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 |
|---|---|---|
| Candin, Intradermal SolutionInjection at the base of the selected wart | Drug | Candin treatment |
| PlaceboInjection at the base of the selected wart | Drug | Placebo |
Primary outcome
Number of participants with complete resolution of the treatment wart
Time frame: Twelve weeks after last injection
Absence of visual or measurable wart maintained through the entire Observational Period for injected wart
4 secondary outcomes
Time to wart clearance
Time frame: Up to 27 weeks
Number of participants with clinical clearance of at least 50% of all measured warts
Time frame: Up to 27 weeks
Number of participants with clinical clearance of all measured warts
Time frame: Up to 27 weeks
Time to clinical clearance of all measured warts
Time frame: Up to 27 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candin, Intradermal Solution in people with Common Warts (Verruca Vulgaris), run by Nielsen BioSciences, Inc. at 18 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 2 inclusion and 8 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the treatment wart (time frame: Twelve weeks after last injection). 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 5 Sep 2025.