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Completed

NCT Number: NCT01757392

Candin Safety & Efficacy Study for the Treatment of Warts

The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).

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Key information

Conditions

Warts DNA Virus Infections Human Papilloma Virus Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

About this study

The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have at least 3 and not more than 10 common warts not located on the palms or digits
  • Positive DTH response to Candin® required

Exclusion criteria

  • No previous medical treatment for warts other than OTC
  • No immunocompromising medical conditions or medicines allowed
  • No preexisting inflammatory conditions at treatment site allowed

Treatment and study plan

Candida albicans Skin Test Antigen

Biological

0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.

Other names: Candin®

Primary outcomes

  1. Number of Participants With Complete Resolution of Primary Injected Wart

    Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Secondary outcomes

  1. Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits

    Time frame: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months

Sponsors and collaborators

Lead sponsor

Nielsen BioSciences, Inc.

Industry

Registry information

Official study title

Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 28, 2012
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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