Clinical trial NCT02393417: Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Verruca vulgaris
Common Warts
Lead sponsor: Nielsen BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Men or women between the ages of 18 and 65 years inclusively at time of consent
2. Subjects presenting with 3 to 20 injectable common warts (verruca vulgaris) for at least 12 weeks at the time of the Baseline Visit
3. 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
4. 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
5. 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)
6. Mentally and legally capable of giving informed consent prior to any study related procedures

Exclusion Criteria:

1. 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
2. Subject has been diagnosed with diabetes mellitus
3. Subject has a history of keloid formation
4. 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
5. 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
6. 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
7. Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment designed to stimulate immune response (except for treatments already listed in exclusion criterion 6) within 12 weeks of the Baseline Visit
8. Recalcitrant warts defined as those not successfully treated by 5 or more treatments (excluding OTC treatments)
9. Abnormal (low \< 5 mm or high \>25 mm) baseline result to the Delayed Type Hypersensitivity (DTH) test
10. Subject has a condition or treatment resulting in being immunocompromised
11. 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
12. 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)
13. Previous treatment of warts with any type of intralesional injection with candida extract (including CANDIN)

Primary outcomes:
measure: Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit
timeFrame: 45 weeks
Secondary outcomes:
measure: Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit
timeFrame: 45 weeks
measure: Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit
timeFrame: 4 month follow up visit at 45 weeks
measure: Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)
timeFrame: 45 weeks
measure: Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)
timeFrame: 45 weeks
measure: Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts
timeFrame: 45 weeks
measure: Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)
timeFrame: 45 weeks
measure: Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)
timeFrame: 45 weeks
measure: Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%
timeFrame: 45 weeks
Other outcomes:
measure: Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart
timeFrame: 45 weeks
measure: Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.
timeFrame: 45 weeks
measure: Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History
timeFrame: 45 weeks
measure: The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts
timeFrame: 45 weeks
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center PLLC
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Newport Beach
country: United States
facility: Silverberg MD Inc.
state: California
city: Needham
country: United States
facility: Metro Boston Clinical Partners, LLC
state: Massachusetts
city: Watertown
country: United States
facility: BayState Clinical Trials
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology Clinical Trials
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Austin
country: United States
facility: Austin Institute for Clinical Research Inc.
state: Texas
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Nielsen BioSciences, Inc.
name: Thomas Carpenter, DVM, PhD
role: STUDY_DIRECTOR
References:
citation: 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.