Candin for the Treatment of Common Warts

NCT05889845 | Completed Phase 3 FDA Drug

• 1 other identifier: CFW-3A
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 18

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

Conditions

Common Warts (Verruca Vulgaris)

Keywords

Common wart; Intralesional injection; Candida albicans; Immunotherapy

Outcome Measures

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

  Twelve weeks after last injection

Secondary Outcomes (4)

• Time to wart clearance

  Up to 27 weeks

• Number of participants with clinical clearance of at least 50% of all measured warts

  Up to 27 weeks

• Number of participants with clinical clearance of all measured warts

  Up to 27 weeks

• Time to clinical clearance of all measured warts

  Up to 27 weeks

Study Arms (2)

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

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

Drug: Placebo

Interventions

Candin, Intradermal Solution DRUG

Injection at the base of the selected wart

Candin treatment

Placebo DRUG

Injection at the base of the selected wart

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nielsen BioSciences, Inc.: lead

Study Sites (18)

Cahaba Dermatology

Birmingham, Alabama, 35244, United States

Location

Arkansas Pediatric Clinic

Bryant, Arkansas, 72022, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Dermatology Clinic of Arkansas

Hot Springs, Arkansas, 71913, United States

Location

Velocity Clinical La Mesa

La Mesa, California, 91942, United States

Location

Long Beach Research

Long Beach, California, 90805, United States

Location

Integrative Skin Research

Sacramento, California, 95815, United States

Location

Velocity Clinical Englewood

Englewood, Colorado, 80110, United States

Location

Kaminska Dermatology

Chicago, Illinois, 60657, United States

Location

Integrated Dermatology of Newton-Brighton

Brighton, Massachusetts, 02135, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Schlessinger MD

Omaha, Nebraska, 68144, United States

Location

Advocare Berlin Medical Associates

Berlin, New Jersey, 08009, United States

Location

Bryn Mawr Health Center

Newtown Square, Pennsylvania, 19073, United States

Location

Velocity Clinical Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Velocity Clinical Hampton

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unblinded site staff will prepare syringes of study drug for administration by blinded study staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Study

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 5, 2023
• Study Start: January 22, 2025
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)