Candin for the Treatment of Common Warts

NCT ID: NCT05889845

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2025-08-27

Brief 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

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Candin, Intradermal Solution

Intervention Type: DRUG

Injection at the base of the selected wart

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Injection at the base of the selected wart

Interventions

Candin, Intradermal Solution

Injection at the base of the selected wart

Intervention Type: DRUG

Placebo

Injection at the base of the selected wart

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nielsen BioSciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cahaba Dermatology

Birmingham, Alabama, United States

Arkansas Pediatric Clinic

Bryant, Arkansas, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Dermatology Clinic of Arkansas

Hot Springs, Arkansas, United States

Velocity Clinical La Mesa

La Mesa, California, United States

Long Beach Research

Long Beach, California, United States

Integrative Skin Research

Sacramento, California, United States

Velocity Clinical Englewood

Englewood, Colorado, United States

Kaminska Dermatology

Chicago, Illinois, United States

Integrated Dermatology of Newton-Brighton

Brighton, Massachusetts, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Schlessinger MD

Omaha, Nebraska, United States

Advocare Berlin Medical Associates

Berlin, New Jersey, United States

Bryn Mawr Health Center

Newtown Square, Pennsylvania, United States

Velocity Clinical Spartanburg

Spartanburg, South Carolina, United States

DermResearch

Austin, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, United States

Velocity Clinical Hampton

Hampton, Virginia, United States

Countries

United States

Other Identifiers

CFW-3A

Identifier Type: -

Identifier Source: org_study_id