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Spots Global Cancer Trial Database for Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

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Trial Identification

Brief Title: 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 ID: NCT02393417

Conditions

Warts

Interventions

CANDIN
Placebo

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Johnson Dermatology, Fort Smith, Arkansas, United States

Northwest Arkansas Clinical Trials Center PLLC, Rogers, Arkansas, United States

California Dermatology and Clinical Research Institute, Encinitas, California, United States

Silverberg MD Inc., Newport Beach, California, United States

Metro Boston Clinical Partners, LLC, Needham, Massachusetts, United States

BayState Clinical Trials, Watertown, Massachusetts, United States

Hamzavi Dermatology Clinical Trials, Fort Gratiot, Michigan, United States

Minnesota Clinical Study Center, Fridley, Minnesota, United States

Dermatology Consulting Services, High Point, North Carolina, United States

Oregon Medical Research Center, Portland, Oregon, United States

Austin Institute for Clinical Research Inc., Austin, Texas, United States

DermResearch Inc., Austin, Texas, United States

Texas Dermatology and Laser Specialists, San Antonio, Texas, United States

Dermatology Research Center, Inc., Salt Lake City, Utah, United States

The Education and Research Foundation, Inc., Lynchburg, Virginia, United States

Contact Details

Name: Thomas Carpenter, DVM, PhD

Affiliation: Nielsen BioSciences, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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