Candin Safety & Efficacy Study for the Treatment of Warts

NCT01757392 | Completed Phase 2 Results

• 1 other identifier: Nieslen Protocol CFW-2c
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Warts; Human Papilloma Virus

Keywords

Treatment; common wart lesions; (verruca vulgaris)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Resolution of Primary Injected Wart

  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

  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

Study Arms (1)

Candin® 0.3 mL

EXPERIMENTAL

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

Biological: Candida albicans Skin Test Antigen

Interventions

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.

Also known as: Candin®

Candin® 0.3 mL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nielsen BioSciences, Inc.: lead

Study Sites (1)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Burney
• Organization: Nielsen Biosciences, Inc

david@nielsenbio.com

858-571-2726

Study Officials

• Sandy M Johnson, MD

  Johnson Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: December 28, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Locations

US (1)