Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)
Condition: Warts
MeSH terms: Warts
Intervention: CANDIN; Placebo
Intervention description: Candida albicans Skin Test Antigen for Cellular Hypersensitivity; 0.9% Sodium Chloride Injection USP (non-preserved)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Verruca vulgaris; Common Warts

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)