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

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ClinicalTrials.gov Identifier: NCT02393417
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Nielsen BioSciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Warts Biological: CANDIN Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Cohort 1
0.3 mL of CANDIN administered intralesionally in the largest common wart
Biological: CANDIN
Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Experimental: Cohort 2
0.5 mL of CANDIN administered intralesionally in the largest common wart
Biological: CANDIN
Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Experimental: Cohort 3
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
Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Placebo Comparator: Pooled Placebo
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
0.9% Sodium Chloride Injection USP (non-preserved)




Primary Outcome Measures :
  1. The number and proportion of subjects with the primary injected wart(s) completely resolved at any treatment or Follow-up Visit [ Time Frame: 45 weeks ]

Secondary Outcome Measures :
  1. Incidence of site injection Adverse Event (AE) for all subjects and Treatment-Emergent Adverse Event (TEAE) for subjects randomized to CANDIN [ Time Frame: 45 weeks ]
  2. Proportion of subjects with a complete resolution of all common warts at any treatment or Follow-up Visit [ Time Frame: 45 weeks ]
  3. Number of injection visits needed to obtain complete resolution of the primary injected wart(s) [ Time Frame: 45 weeks ]
  4. Number of injection visits needed to obtain complete resolution of all common warts [ Time Frame: 45 weeks ]
  5. Proportion of subjects with a partial resolution of the primary injected wart(s) based on the wart(s) diameter at the Efficacy Evaluation Visit [ Time Frame: 45 weeks ]
  6. Proportion of subjects without a complete resolution of the primary injected warts and with a partial resolution of all measured common warts based on the wart diameter at the Efficacy Evaluation Visit [ Time Frame: 45 weeks ]
  7. Proportion of subjects without scarring at the site of resolved primary and non-primary injected wart(s) [ Time Frame: 45 weeks ]
  8. Proportion of subjects without hypopigmentation at the site of resolved primary and non-primary injected wart(s) [ Time Frame: 45 weeks ]
  9. Proportion of subjects with complete resolution of all common warts (other than genital, plantar, periungual, facial and flat) [ Time Frame: 45 weeks ]

Other Outcome Measures:
  1. Change from Baseline in a panel of 52 serum biomarkers of inflammatory/immune function at Visit 5 and the Efficacy Evaluation Visit for Cohort 1 [ Time Frame: 45 weeks ]
  2. Incidence of recurrence of measured warts at treatment or Follow-up Visits [ Time Frame: 45 weeks ]
  3. Proportion of subjects who present new common warts in anatomical area(s) where no common warts were present at Baseline [ Time Frame: 45 weeks ]
  4. Correlation between the age (duration) of the largest primary injected wart and the treatment outcome (complete resolution of the largest primary injected wart) [ Time Frame: 45 weeks ]
  5. Correlation between the age (duration) of the largest primary injected wart and the incidence of recurrence of warts at any visit. [ Time Frame: 45 weeks ]
  6. The effect of the treatment history on the treatment outcome (complete resolution of the largest primary injected wart). [ Time Frame: 45 weeks ]
  7. The effect of the treatment history on the incidence of recurrence of measured warts [ Time Frame: 45 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393417


Locations
United States, Arkansas
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
Northwest Arkansas Clinical Trials Center PLLC
Rogers, Arkansas, United States, 72758
United States, California
California Dermatology and Clinical Research Institute
Encinitas, California, United States, 92024
Silverberg MD Inc.
Newport Beach, California, United States, 92660
United States, Massachusetts
Metro Boston Clinical Partners, LLC
Needham, Massachusetts, United States, 02492
BayState Clinical Trials
Watertown, Massachusetts, United States, 02472
United States, Michigan
Hamzavi Dermatology Clinical Trials
Fort Gratiot, Michigan, United States, 48059
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
Austin Institute for Clinical Research Inc.
Austin, Texas, United States, 78660
DermResearch Inc.
Austin, Texas, United States, 78759
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84117
United States, Virginia
The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Nielsen BioSciences, Inc.
Investigators
Study Director: Thomas Carpenter, DVM, PhD Nielsen BioSciences, Inc.

Publications of Results:
Responsible Party: Nielsen BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT02393417     History of Changes
Other Study ID Numbers: CFW-2D
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Nielsen BioSciences, Inc.:
Verruca vulgaris
Common Warts

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases