Study With Candida Antigen for Treatment of Warts - Full Text View

Sponsors and Collaborators:	University of Arkansas Allermed Laboratories, Inc.
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00569231

Purpose

The purpose of this study is to look at how people respond to the treatment of warts through use of the Candida Antigen to get an immune response to rid the body of human papillomavirus (HPV). The immune system is the part of the body that fights infections like HPV which causes warts. This research study will examine the response of your wart when injected with a portion of a common yeast(candida) which is the study drug. Your immune system response will also be looked by doing a test called an ELISPOT assay. This test is done with a blod sample and a sample of one of your warts. The results of this test may help us to determine how the candida antigen affects your wart.

Condition	Intervention	Phase
Warts HPV	Drug: Candida Antigen	Phase I

MedlinePlus related topics: Warts

Drug Information available for: BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Measurement of overall percentage of resolution of the injected ward from the initial visit. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurement of resolution of untreated 3 anatomically non-injected warts from initial visit. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
One: Experimental	Drug: Candida Antigen 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be ages 18-50.
Female subjects of child-bearing potential must have a negative urine pregnancy test before each treatment.
Female subjects of child-bearing potential agree to use a reliable form of birth- control as the risks associated with candida antigens during pregnancy are not known.
Subjects must have two or more cutaneous, non-genital, non-facial warts.
Subjects must be able to provide written, informed consent.
Subjects must be willing to comply with the requirements of the protocol.
Subjects vital signs must be within the following parameters at time of enrollment:
- Blood Pressure - <150/95 mmHg
- Temperature - <100.4° F
- Pulse Rate - 50 to 100 beats/minute
- Respiratory Rate - <24 breaths/minute

Exclusion Criteria:

Subjects who have a history of disease or treatment that has caused the subject to be immunosuppressed to include, but not limited to, cancer, HIV, or organ transplantation. Immunosuppression will be determined only by medical history.
Subjects who are pregnant, lactating, or attempting to become pregnant, as the risks associated with candida antigens during pregnancy are not known.
Subjects who have only genital or facial warts.
Subjects who are unable to return for follow-up visits or comply with the protocol.
Subjects who have a known allergy to Thimerosol or the candida antigen.
Subjects who have a history of asthma as determined by a medical history or treatment for an asthmatic episode.
Subjects who have any type of diabetes.
Subjects who are currently using non-selective Beta Blockers.
Subjects who are currently using H2 antagonists (e.g., cimetidine). There will be a 24 hour washout period for any use of H2 antagonists prior to beginning treatment in the study.
Subjects who have a history of keloid formation.
Subjects who have a history of alcohol or illicit drug abuse, as determined only by medical history.
Subjects who have had previous treatment with candida antigens for their warts.
Subjects who are currently using any other treatments for their warts. This includes prescription or over-the-counter medications. Subjects must have a wash¬out period of 30 days for any previous treatments prior to beginning the study.
Subjects with a blood pressure >150/95, temperature >100.4° F, pulse rate <50 or >100 beats per minute, and respiratory rate >24 at time of enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569231

Contacts

Contact: Joni Pharis, RN

501- 603-1505

PharisJoni@uams.edu

Locations

United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Mayumi Nakagawa, MD, PhD

Sponsors and Collaborators

University of Arkansas

Allermed Laboratories, Inc.

Investigators

Principal Investigator:

Mayumi Nakagawa, MD, PhD

University of Arkansas

More Information

Publications:

1 Majewski S, Jablonska S. Human papillomavirus-associated tumors of the skin and mucosa. J Am Acad Dermatol 1997;36:659-85. 2 Baker GE, Tyring SK. Therapeutic approaches to papillomavirus infections. Dermatologic Clinics 1997;15(2):331-340. 3 Miller DM, Brodell RT. Human papillomavirus infection: Treatment options for warts. Am Fam Phys 1996;53(1):135-43. 4 Quan MB, Moy RL. The role of human papillomavirus in carcinoma. J Am Acad Dermatol 1991;25:698-705. 5 Pfister H. Human papillomavirus and skin cancer. Seminars in Cancer Biology 1992;3(5):263-271. 6 Messing AM, Epstein WL. Natural history of warts: A two-year study. Arch Dermatol 1963;87:306-10. 7 Johnson SM, Brodell RT. Treating warts: a review of therapeutic options. Consultant 1999;39(1):253-266. 8 Brunk D. Injection of Candida antigen works on warts. Skin and Allergy News. 1999; 30(12):5. 9 Johnson SM, Roberson PK, Horn TD. Intralesional injection of mumps or candida antigens: a novel immnotherapy for warts. Arch Dermatol 2001;137:451-455. 10 Horn TD, Johnson SM, Roberson PK, Helm RM. Intralesional Immunotherapy with Mumps, Candida, and Trichophyton Skin Test Antigens: A Single-Blinded, Randomized, and Controlled Trial. Arch Dermatol 2005:141:589-593.

Responsible Party:	University of Arkansas for Medical Sciences ( L. D. Milne, PhD/Vice Chancellor for Research and Academic Affairs )
Study ID Numbers:	46487
Study First Received:	December 6, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00569231
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Warts
Candida
HPV
Injections, Intralesional
Immune System

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Warts
Skin Diseases

DNA Virus Infections
Papillomavirus Infections
Torulopsis

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009