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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Warts, Human Papilloma Virus

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Trial Information

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


The primary objective of this study is to determine the safety of Candin® (Candida albicans
Skin Test Antigen) at either 0.3 or 0.5 mL dose levels at up to 6 monthly injections (a
maximal, cumulative dose of 1.9 or 3.1 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 and 0.5 mL dose levels 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Candin® (Candida albicans Skin Test Antigen) at 0.3 and 0.5 ml dose levels at up to 6 monthly injections for treating common warts (Verruca vulgaris)

Outcome Description:

Symptoms will be evaluated daily for 7 days following each monthly treatment for safety

Outcome Time Frame:

Monthly evaluations for up to 5 months

Safety Issue:

Yes

Principal Investigator

Sandy M Johnson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johnson Dermatology

Authority:

United States: Food and Drug Administration

Study ID:

Allermed Protocol CFW-2c

NCT ID:

NCT01757392

Start Date:

September 2012

Completion Date:

October 2014

Related Keywords:

  • Warts
  • Human Papilloma Virus
  • Treatment
  • common wart lesions
  • (verruca vulgaris)
  • Papilloma
  • Warts

Name

Location

Johnson DermatologyFort Smith, Arkansas  72916