Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

NCT02393417 | Completed Phase 2 Results

• 1 other identifier: CFW-2D
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 15

Brief Summary

This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.

Conditions

Warts

Keywords

Verruca vulgaris; Common Warts

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit

  Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart

  45 weeks

Secondary Outcomes (8)

• Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit

  45 weeks

• Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit

  4 month follow up visit at 45 weeks

• Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)

  45 weeks

• Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)

  45 weeks

• Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts

  45 weeks

Other Outcomes (4)

• Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart

  45 weeks

• Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.

  45 weeks

• Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History

  45 weeks

Study Arms (4)

Cohort 1

EXPERIMENTAL

0.3 mL of CANDIN administered intralesionally in the largest common wart

Biological: CANDIN

Cohort 2

EXPERIMENTAL

0.5 mL of CANDIN administered intralesionally in the largest common wart

Biological: CANDIN

Cohort 3

EXPERIMENTAL

0.3 mL of CANDIN administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

Biological: CANDIN

Pooled Placebo

PLACEBO COMPARATOR

0.3 mL or 0.5 mL administered intralesionally in the largest common wart, or 0.3 mL administered intralesionally in up to 4 warts at the same visit (up to 1.2 mL total injected volume)

Other: Placebo

Interventions

CANDIN BIOLOGICAL

Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Cohort 1; Cohort 2; Cohort 3

Placebo OTHER

0.9% Sodium Chloride Injection USP (non-preserved)

Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women between the ages of 18 and 65 years inclusively at time of consent
• Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit
• Subject's common warts for injection must measure between 3 and 20 mm at Baseline Visit and be located on hands, feet (excluding soles), limbs, and/or trunk. Flat, plantar, facial, periungual, genital warts or warts in region of pre-existing inflammatory condition are excluded from injection
• Subjects enrolled into Cohort 3 must have common warts for injection in at least 2 different anatomical regions defined as: left arm, right arm, left hand, right hand, left leg, right leg, left foot (excluding sole), right foot (excluding sole) and torso
• Subject, male or female is willing to use effective contraceptive method for at least 30 days before the Baseline Visit and at least 30 days after the last study drug administration unless not of childbearing potential as defined as post-menopausal for at least 2 years (females) or surgically sterile (tubal ligation, oophorectomy, or hysterectomy for females, and vasectomy for males). The only contraceptive use exceptions would be individuals in exclusive same sex partnerships and individuals who agree to remain non-sexually active for the duration of the study. Acceptable contraceptive methods for subjects include:
• Barrier methods, such as condom, sponge or diaphragm, combined with spermicide in foam, gel or cream;
• Hormonal contraception (oral, intramuscular, implant or transdermal which includes Depo-Provera, Evra and Nuvaring);
• Intrauterine device (IUD)
• Mentally and legally capable of giving informed consent prior to any study related procedures

You may not qualify if:

• Presence of systemic or localized diseases, conditions, or medications that could interfere with assessment of safety and efficacy or that compromise immune function including psoriasis
• Subject has been diagnosed with diabetes mellitus
• Subject has a history of keloid formation
• Injectable common wart(s) located in areas with existing dermatologic conditions (such as psoriasis) or with an underlying inflammatory conditions (such as arthritic joints), or tattoos or implants/piercing/hardware or marking that may conceal responses or reactions are excluded from injection
• Existing/planned pregnancy, childbirth in the past six months prior to the Baseline Visit, or breast feeding, or plan on donating eggs or sperm during the study and in the month following the last injection
• Treatment of warts with liquid nitrogen, carbon dioxide, electrodessication, laser, surgery, simple occlusion (e.g. duct tape) salicylic or related acids, OTC treatments, cantharidin, or other treatments within 4 weeks of the Baseline Visit
• Recalcitrant warts defined as those not successfully treated by 5 or more treatments (excluding OTC treatments)
• Abnormal (low \< 5 mm or high \>25 mm) baseline result to the Delayed Type Hypersensitivity (DTH) test
• Subject has a condition or treatment resulting in being immunocompromised
• Systemic treatment (such as oral or injected) with cimetidine, zinc supplements at a dose higher than 20 mg of elemental zinc daily or an immunosuppressive drug (such as: azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, systemic steroids, etc.) within 12 weeks of the Baseline Visit
• Subject has used any investigational agent within 30 days prior to the Baseline Visit or within 5 half-lives of that investigational agent prior to the Baseline Visit (whichever is longer)
• Previous treatment of warts with any type of intralesional injection with candida extract (including CANDIN)

Sponsors & Collaborators

• Nielsen BioSciences, Inc.: lead

Study Sites (15)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Northwest Arkansas Clinical Trials Center PLLC

Rogers, Arkansas, 72758, United States

Location

California Dermatology and Clinical Research Institute

Encinitas, California, 92024, United States

Location

Silverberg MD Inc.

Newport Beach, California, 92660, United States

Location

Metro Boston Clinical Partners, LLC

Needham, Massachusetts, 02492, United States

Location

BayState Clinical Trials

Watertown, Massachusetts, 02472, United States

Location

Hamzavi Dermatology Clinical Trials

Fort Gratiot, Michigan, 48059, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Austin Institute for Clinical Research Inc.

Austin, Texas, 78660, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84117, United States

Location

The Education and Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Related Publications (2)

• Kim KH, Horn TD, Pharis J, Kincannon J, Jones R, O'Bryan K, Myers J, Nakagawa M. Phase 1 clinical trial of intralesional injection of Candida antigen for the treatment of warts. Arch Dermatol. 2010 Dec;146(12):1431-3. doi: 10.1001/archdermatol.2010.350. No abstract available.

  PMID: 21173332 RESULT

• Smith SR, Esch RE, Nielsen HS, Johnson SM. Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens. Dermatol Ther (Heidelb). 2025 May;15(5):1135-1152. doi: 10.1007/s13555-025-01387-1. Epub 2025 Mar 29.

  PMID: 40155509 DERIVED

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Burney, PhD, MBA
• Organization: Nielsen BioSciences Inc.

david@nielsenbio.com

858-571-2726

Study Officials

• Thomas Carpenter, DVM, PhD

  Nielsen BioSciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-05

Locations

US (15)