Candin Safety & Efficacy Study for the Treatment of Warts

• Sponsor: Nielsen BioSciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01757392
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Warts; Human Papilloma Virus	Biological: Candida albicans Skin Test Antigen	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Candin® 0.3 mL Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.	Biological: Candida albicans Skin Test Antigen; 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.; Other Names: Candin®

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johnson Dermatology	Fort Smith	Arkansas	United States	72916

Sponsors and Collaborators

• Nielsen BioSciences, Inc.

Investigators

• Principal Investigator: Sandy M Johnson, MD, Johnson Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nielsen BioSciences, Inc.
• ClinicalTrials.gov Identifier: NCT01757392
• Other Study ID Numbers: Nieslen Protocol CFW-2c
• First Posted: Dec 28, 2012
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Nielsen BioSciences, Inc.: Treatment; common wart lesions; (verruca vulgaris)
• Additional relevant MeSH terms: Warts; Papilloma

Study Results

Participant Flow

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Period Title: Overall Study
STARTED	39
COMPLETED	35
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesion resolves or up to 6 injections.
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (11.76)
Sex: Female, Male (Count of Participants)
Female	17 48.6%
Male	18 51.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	34 97.1%
Hispanic	1 2.9%
Region of Enrollment (participants) [Number]
United States	35 100%
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	87.32 (22.508)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	173.52 (10.982)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.66 (5.6)

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Measure Participants	35
Count of Participants [Participants]	19 54.3%

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Subjects experiencing complete resolution of the primary injected wart

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Measure Participants	19
One Injection visit	5 14.3%
Two Injection visits	4 11.4%
Three Injection visits	3 8.6%
Four Injection visits	4 11.4%
Five Injection visits	1 2.9%
Six Injection visits	2 5.7%

3. Post-Hoc Outcome

Title	Number of Participants With Complete Resolution of the First Non-injected Wart by 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Measure Participants	18
One injection visit	5 14.3%
Two injection visits	2 5.7%
Three Injection visits	5 14.3%
Four Injection visits	1 2.9%
Five Injection visits	0 0%
Six Injection visits	5 14.3%

4. Post-Hoc Outcome

Title	Number of Participants With Complete Resolution of All Qualified Warts by 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Measure Participants	12
One injection visit	0 0%
Two injection visits	0 0%
Three injection visits	2 5.7%
Four injection visits	4 11.4%
Five injection visits	3 8.6%
Six injection visits	3 8.6%

5. Post-Hoc Outcome

Title	Recurrence of Resolved Primary Wart at Follow up 2 Visit
Description	Number of participants with recurrence of primary wart seen at the final follow up visit
Time Frame	4 months after last injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.
Measure Participants	19
Count of Participants [Participants]	4 11.4%

Adverse Events

Time Frame	All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)
Arm/Group Title	Candin® 0.3 mL
Arm/Group Description	Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections.
All Cause Mortality
	Candin® 0.3 mL
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	Candin® 0.3 mL
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Hepatobiliary disorders
Cholecystitis	1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Candin® 0.3 mL
	Affected / at Risk (%)	# Events
Total	34/35 (97.1%)
Gastrointestinal disorders
Diarrhea	5/35 (14.3%)
Nausea	4/35 (11.4%)
General disorders
Injection site erythema	32/35 (91.4%)
Injection site Pain	32/35 (91.4%)
Injection site swelling	31/35 (88.6%)
Injection site pruritus	20/35 (57.1%)
Fatigue	10/35 (28.6%)
Injection site exfoliation	9/35 (25.7%)
Influenza like illness	8/35 (22.9%)
Injection site vesicles	5/35 (14.3%)
Infections and infestations
Sinusitis	3/35 (8.6%)
Upper respiratory tract infection	2/35 (5.7%)
Investigations
Alanine aminotranferase increased	2/35 (5.7%)
Nervous system disorders
Headache	11/35 (31.4%)
Respiratory, thoracic and mediastinal disorders
Wheezing	4/35 (11.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.