Completed

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

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What is being tested

Candin, Intradermal Solution

+ Placebo

Drug
Who is being recruted

DNA Virus Infections+7

+ Infections

+ Skin Diseases

Over 12 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorNielsen BioSciences, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 22, 2025

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT05889845
Principal SponsorNielsen BioSciences, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

330 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousTumor Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralSkin and Connective Tissue DiseasesPapillomavirus Infections

Criteria

2 inclusion criteria required to participate
At least 3, but not more than 20 common warts (Verruca vulgaris)
Willing to agree to use adequate contraception methods during the study
8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

Cahaba Dermatology

Birmingham, United StatesOpen Cahaba Dermatology in Google Maps
Suspended

Arkansas Pediatric Clinic

Bryant, United States
Suspended

Johnson Dermatology

Fort Smith, United States
Suspended

Dermatology Clinic of Arkansas

Hot Springs, United States
Completed18 Study Centers