Candin for the Treatment of Common Warts

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nielsen BioSciences, Inc.

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