ClinicalTrials.gg
CompletedNCT05889845Updated Sep 5, 2025

Candin for the Treatment of Common Warts

A Phase 3 interventional study of Candin, Intradermal Solution and Placebo in Common Warts (Verruca Vulgaris), sponsored by Nielsen BioSciences, Inc.. Completed at 18 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Nielsen BioSciences, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2025, 1 year 2 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Common Warts (Verruca Vulgaris)

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Keywords

  • Common wart
  • Intralesional injection
  • Candida albicans
  • Immunotherapy
03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's enrollment of 330 is above the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Nielsen BioSciences, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 3, but not more than 20 common warts (Verruca vulgaris)
  • Willing to agree to use adequate methods during the study

Exclusion criteria

Exclusion Criteria:

  • 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 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 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 [topical or inhaled steroids are acceptable]).
  • Use of cantharidin or an agent or device within the 30 days prior to the Baseline Visit or during the study
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    Candin treatment

    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

    Drug: Candin, Intradermal Solution

  • Placebo comparator
    Placebo

    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

    Drug: Placebo

Interventions

  • DrugCandin, Intradermal Solution

    Injection at the base of the selected wart

  • DrugPlacebo

    Injection at the base of the selected wart

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Twelve weeks after last injection

Secondary outcomes

  1. 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.

    Time frame: Up to 27 weeks

  2. 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.

    Time frame: Up to 27 weeks

  3. 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.

    Time frame: Up to 27 weeks

  4. 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.

    Time frame: Up to 27 weeks

07

Study locations

18 sites
  • Cahaba Dermatology
    Birmingham, Alabama 35244, United States
  • Arkansas Pediatric Clinic
    Bryant, Arkansas 72022, United States
  • Johnson Dermatology
    Fort Smith, Arkansas 72916, United States
  • Dermatology Clinic of Arkansas
    Hot Springs, Arkansas 71913, United States
  • Velocity Clinical La Mesa
    La Mesa, California 91942, United States
  • Long Beach Research
    Long Beach, California 90805, United States
  • Integrative Skin Research
    Sacramento, California 95815, United States
  • Velocity Clinical Englewood
    Englewood, Colorado 80110, United States
  • Kaminska Dermatology
    Chicago, Illinois 60657, United States
  • Integrated Dermatology of Newton-Brighton
    Brighton, Massachusetts 02135, United States
  • Hamzavi Dermatology
    Fort Gratiot, Michigan 48059, United States
  • Schlessinger MD
    Omaha, Nebraska 68144, United States
  • Advocare Berlin Medical Associates
    Berlin, New Jersey 08009, United States
  • Bryn Mawr Health Center
    Newtown Square, Pennsylvania 19073, United States
  • Velocity Clinical Spartanburg
    Spartanburg, South Carolina 29303, United States
  • DermResearch
    Austin, Texas 78759, United States
  • Austin Institute for Clinical Research
    Pflugerville, Texas 78660, United States
  • Velocity Clinical Hampton
    Hampton, Virginia 23666, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05889845
Lead sponsor
Nielsen BioSciences, Inc.
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Jan 22, 2025
Primary completion
Aug 27, 2025
Completion
Aug 27, 2025
Last update
Sep 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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