Candin for the Treatment of Common Warts

Nielsen BioSciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Common Warts (Verruca Vulgaris)

Treatments: Drug: Candin, Intradermal Solution; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05889845

CFW-3A

Details and patient eligibility

About

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

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 2 patient groups, including a placebo group

Candin treatment

Experimental group

Description:

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

Treatment:

Drug: Candin, Intradermal Solution

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo