Candin Safety & Efficacy Study for the Treatment of Warts

NCT ID: NCT01757392

Last Updated: 2021-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Warts Human Papilloma Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Candin® 0.3 mL

Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.

Group Type EXPERIMENTAL

Candida albicans Skin Test Antigen

Intervention Type BIOLOGICAL

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

Interventions

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Candida albicans Skin Test Antigen

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Candin®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nielsen BioSciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandy M Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Johnson Dermatology

Locations

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Johnson Dermatology

Fort Smith, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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Nieslen Protocol CFW-2c

Identifier Type: -

Identifier Source: org_study_id

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