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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

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Skin Diseases, Viral

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Skin Diseases, Infectious

Pharmaceutical Solutions

All Drugs and Chemicals

Immunomodulating Agents

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

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

Injection at the base of the selected wart

Candin, Intradermal Solution

Placebo

Nielsen Central Contact

Jennifer Perry

Tim Dugan

Sandra Johnson, MD

Valerie Horne

Yelena Quintanilla

Sydney Fong

Theresa O'Lonergan

Ghadeer Samhan

Stella Schandorf

Lee Campbell

Kayleigh Koziol

Jeanette Caruso

Michelle Golding

Allison Kelly

Karina Garcia

Candice Nkwo

Celeste Katona

Kenji Mizoguchi

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

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.

Randomized, Double-Blind, Placebo-Controlled Study

Unblinded site staff will prepare syringes of study drug for administration by blinded study staff

Candin for the Treatment of Common Warts

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

Absence of visual or measurable wart maintained through the entire Observational Period for injected wart

Time from first injection to achieving clinical clearance of the treatment wart. Clinical clearance is no evidence of the wart by visual inspection.

The injected wart and up to five other warts will be measured. Clinical clearance is no evidence of the wart by visual inspection.

Nielsen BioSciences, Inc.

Spots Global Cancer Trial Database for candin, intradermal solution