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Trial Title: Candin for the Treatment of Common Warts

NCT ID: NCT05889845

Condition: Common Warts (Verruca Vulgaris)

Conditions: Official terms:
Warts

Conditions: Keywords:
Common wart
Intralesional injection
Candida albicans
Immunotherapy

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized, Double-Blind, Placebo-Controlled Study

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

Intervention:

Intervention type: Drug
Intervention name: Candin, Intradermal Solution
Description: Injection at the base of the selected wart
Arm group label: Candin treatment

Intervention type: Drug
Intervention name: Placebo
Description: Injection at the base of the selected wart
Arm group label: Placebo

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.

Criteria for 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

Gender: All

Minimum age: 12 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cahaba Dermatology

Address:
City: Birmingham
Zip: 35244
Country: United States

Status: Recruiting

Contact:
Last name: Jennifer Perry

Phone: 205-778-1564
Email: jperry@cahabaderm.com

Facility:
Name: Arkansas Pediatric Clinic

Address:
City: Bryant
Zip: 72022
Country: United States

Status: Recruiting

Contact:
Last name: Tim Dugan

Phone: 501-655-6138
Email: tdugan@burkepharmaceutical.com

Facility:
Name: Johnson Dermatology

Address:
City: Fort Smith
Zip: 72916
Country: United States

Status: Recruiting

Contact:
Last name: Sandra Johnson, MD

Phone: 479-649-3376
Email: drsandy@johnsondermatology.com

Facility:
Name: Dermatology Clinic of Arkansas

Address:
City: Hot Springs
Zip: 71913
Country: United States

Status: Recruiting

Contact:
Last name: Tim Dugan

Phone: 501-620-4449
Email: tdugan@burkepharmaceutical.com

Facility:
Name: Velocity Clinical La Mesa

Address:
City: La Mesa
Zip: 91942
Country: United States

Status: Recruiting

Contact:
Last name: Valerie Horne

Phone: 619-567-1550
Email: vhorne@velocityclinical.com

Facility:
Name: Long Beach Research

Address:
City: Long Beach
Zip: 90805
Country: United States

Status: Recruiting

Contact:
Last name: Yelena Quintanilla

Phone: 562-471-3773
Email: yquintanilla@longbeachresearch.com

Facility:
Name: Integrative Skin Research

Address:
City: Sacramento
Zip: 95815
Country: United States

Status: Recruiting

Contact:
Last name: Sydney Fong

Phone: 916-524-1216
Email: sydney@integrativeskinresearch.com

Facility:
Name: Velocity Clinical Englewood

Address:
City: Englewood
Zip: 80110
Country: United States

Status: Recruiting

Contact:
Last name: Theresa O'Lonergan

Phone: 303-293-3733
Email: tolonergan@velocityclinical.com

Facility:
Name: Kaminska Dermatology

Address:
City: Chicago
Zip: 60657
Country: United States

Status: Recruiting

Contact:
Last name: Ghadeer Samhan

Phone: 737-267-2111
Email: kdermofficemanager@gmail.com

Facility:
Name: Integrated Dermatology of Newton-Brighton

Address:
City: Brighton
Zip: 02135
Country: United States

Status: Recruiting

Contact:
Last name: Stella Schandorf

Phone: 617-789-5300
Email: sschandorf@metrobostoncp.com

Facility:
Name: Hamzavi Dermatology

Address:
City: Fort Gratiot
Zip: 48059
Country: United States

Status: Recruiting

Contact:
Last name: Lee Campbell

Phone: 810-455-1612
Email: lcampbell@hamzavi.com

Facility:
Name: Schlessinger MD

Address:
City: Omaha
Zip: 68144
Country: United States

Status: Recruiting

Contact:
Last name: Kayleigh Koziol

Phone: 402-697-6599
Email: kayleigh@lovelyskin.com

Facility:
Name: Advocare Berlin Medical Associates

Address:
City: Berlin
Zip: 08009
Country: United States

Status: Recruiting

Contact:
Last name: Jeanette Caruso

Phone: 916-802-4097
Email: j.caruso@cenexel.com

Facility:
Name: Bryn Mawr Health Center

Address:
City: Newtown Square
Zip: 19073
Country: United States

Status: Recruiting

Contact:
Last name: Michelle Golding

Phone: 610-544-1715
Email: michelle.golding@kglssc.com

Facility:
Name: Velocity Clinical Spartanburg

Address:
City: Spartanburg
Zip: 29303
Country: United States

Status: Recruiting

Contact:
Last name: Allison Kelly

Phone: 864-515-0092
Email: akelly@velocityclinical.com

Facility:
Name: DermResearch

Address:
City: Austin
Zip: 78759
Country: United States

Status: Recruiting

Contact:
Last name: Karina Garcia

Phone: 512-349-9889
Email: karina@vialtrials.com

Contact backup:
Last name: Candice Nkwo

Facility:
Name: Austin Institute for Clinical Research

Address:
City: Pflugerville
Zip: 78660
Country: United States

Status: Recruiting

Contact:
Last name: Celeste Katona

Phone: 512-279-2545
Email: ckatona@atxresearch.com

Facility:
Name: Velocity Clinical Hampton

Address:
City: Hampton
Zip: 23666
Country: United States

Status: Recruiting

Contact:
Last name: Kenji Mizoguchi

Phone: 757-520-5111
Email: kmizoguchi@velocityclinical.com

Start date: March 5, 2024

Completion date: June 2025

Lead sponsor:
Agency: Nielsen BioSciences, Inc.
Agency class: Industry

Source: Nielsen BioSciences, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05889845

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