Clinical trial NCT05889845: Candin for the Treatment of Common Warts
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Common Warts (Verruca Vulgaris)
Keywords: Common wart
Intralesional injection
Candida albicans
Immunotherapy
Lead sponsor: Nielsen BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with complete resolution of the treatment wart
timeFrame: Twelve weeks after last injection
Secondary outcomes:
measure: Time to wart clearance
timeFrame: Up to 27 weeks
measure: Number of participants with clinical clearance of at least 50% of all measured warts
timeFrame: Up to 27 weeks
measure: Number of participants with clinical clearance of all measured warts
timeFrame: Up to 27 weeks
measure: Time to clinical clearance of all measured warts
timeFrame: Up to 27 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Bryant
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Ft. Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Hot Springs
country: United States
facility: Dermatology Clinic of Arkansas
state: Arkansas
city: La Mesa
country: United States
facility: Velocity Clinical La Mesa
state: California
city: Long Beach
country: United States
facility: Long Beach Research
state: California
city: Sacramento
country: United States
facility: Integrative Skin Research
state: California
city: Englewood
country: United States
facility: Velocity Clinical Englewood
state: Colorado
city: Chicago
country: United States
facility: Kaminska Dermatology
state: Illinois
city: Brighton
country: United States
facility: Integrated Dermatology of Newton-Brighton
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Omaha
country: United States
facility: Schlessinger MD
state: Nebraska
city: Berlin
country: United States
facility: Advocare Berlin Medical Associates
state: New Jersey
city: Newtown Square
country: United States
facility: Bryn Mawr Health Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Velocity Clinical Spartanburg
state: South Carolina
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Hampton
country: United States
facility: Velocity Clinical Hampton
state: Virginia
Study officials:
References: