Trial Outcomes & Findings for Study With Candida Antigen for Treatment of Warts (NCT NCT00569231)

Last Updated: 2011-01-25

Results Overview

When the participant completed the protocol, clinical resolution of the injected wart was determined by the overall percentage of resolution from the initial visit. Participants were classified as 'complete responders' if they had complete resolution of the injected wart, 'partial responders' if the injected wart regressed between 25% and 99%, and 'non-responders' if they had not achieved at least 25% regression of the injected wart.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Initial visit to completion of protocol, which is up to 30 weeks

Results posted on

2011-01-25

Participant Flow

Patients for this study were recruited during the period between February 2007 and May 2009 from the outpatient Dermatology Clinic.

Participant milestones

Participant milestones
Measure	Candida Antigen All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Overall Study STARTED	18
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Candida Antigen All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Overall Study Study unrelated surgery	1
Overall Study Airfare expense	2
Overall Study Withdrawal by Subject	1
Overall Study Car accident injury	1
Overall Study Non-compliance	2

Baseline Characteristics

Study With Candida Antigen for Treatment of Warts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candida Antigen n=18 Participants All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	29.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Initial visit to completion of protocol, which is up to 30 weeks

Population: The participants were analyzed if they completed the protocol by achieving complete resolution of the treated wart, receiving the maximum of 10 treatments, or by having less than 25% resolution of the treated wart after 5 treatments.

Outcome measures

Outcome measures
Measure	Candida Antigen n=11 Participants All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Number of Participants With Clinical Resolution of Injected Wart Complete responder	9 Participants
Number of Participants With Clinical Resolution of Injected Wart Partial responder	1 Participants
Number of Participants With Clinical Resolution of Injected Wart Non-responder	1 Participants

SECONDARY outcome

Timeframe: Initial visit to completion of protocol, which is up to 30 weeks

Population: Participants with 1st anatomically distant, non-injected wart were analyzed.

When the participant completed the protocol, clinical resolution of 1st anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.

Outcome measures

Outcome measures
Measure	Candida Antigen n=8 Participants All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart Complete resolution of 1st non-injected wart	6 Participants
Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart Partial resolution of 1st non-injected wart	2 Participants

SECONDARY outcome

Timeframe: Initial visit to completion of protocol, which is up to 30 weeks

Population: The participants with 2nd anatomically distant, non-injected wart were analyzed.

When the participant completed the protocol, clinical resolution of 2nd anatomically distant, non-injected wart was determined by the overall percentage of resolution from the initial visit.

Outcome measures

Outcome measures
Measure	Candida Antigen n=6 Participants All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Initial visit to completion of protocol, which is up to 30 weeks

Population: The interferon-γ enzyme-linked immunospot assay was performed on available samples from participants who completed the study.

Immunologic responses from peripheral blood mononuclear cells collected prior to vaccination and post-vaccination were measured by ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay to human papillomavirus type 57 L1-peptide.

Outcome measures

Outcome measures
Measure	Candida Antigen n=10 Participants All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide	6 Participants

Adverse Events

Candida Antigen

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Candida Antigen n=18 participants at risk All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
Skin and subcutaneous tissue disorders Bullous dermatitis	5.6% 1/18 • Number of events 1 • 3 years, 4 months
General disorders Chills	5.6% 1/18 • Number of events 1 • 3 years, 4 months
General disorders Flu like symptoms	11.1% 2/18 • Number of events 3 • 3 years, 4 months
Nervous system disorders Headache	11.1% 2/18 • Number of events 3 • 3 years, 4 months
Vascular disorders Hematoma	5.6% 1/18 • Number of events 1 • 3 years, 4 months
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • 3 years, 4 months
General disorders Injection site reaction	83.3% 15/18 • Number of events 74 • 3 years, 4 months
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	5.6% 1/18 • Number of events 3 • 3 years, 4 months
Blood and lymphatic system disorders Lymph node pain	5.6% 1/18 • Number of events 2 • 3 years, 4 months
General disorders Malaise	5.6% 1/18 • Number of events 1 • 3 years, 4 months
Musculoskeletal and connective tissue disorders Muscle weakness	11.1% 2/18 • Number of events 2 • 3 years, 4 months
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 3/18 • Number of events 5 • 3 years, 4 months
Skin and subcutaneous tissue disorders Rash	5.6% 1/18 • Number of events 1 • 3 years, 4 months

Additional Information

Mayumi Nakagawa, MD, PhD

University of Arkansas for Medical Sciences

Phone: (501) 686-8635

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place