Study With Candida Antigen for Treatment of Warts

HPV Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569231
• Other study ID #: 46487
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2007
• Last updated: December 29, 2010
• Start date: February 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2010
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 at by doing a test called an ELISPOT assay. This test is done on blood samples. The results of this test may help us to determine how the Candida antigen affects your wart.

Description:

The use of recall antigens for treating warts is not yet Food and Drug Administration (FDA) approved. The primary goal of this work was to assess the safety of Candin as an investigational new drug (IND) for the treatment of warts. In addition, clinical resolution of treated and untreated warts was evaluated and immunologic responses were examined using an ex vivo interferon-γ enzyme-linked immunospot (IFN-γ ELISPOT) assay in order to elucidate the immunologic mechanisms behind the successful regression of warts in patients undergoing Candin injection immunotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HPV
• Warts

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Allermed Laboratories, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Baker GE, Tyring SK. Therapeutic approaches to papillomavirus infections. Dermatol Clin. 1997 Apr;15(2):331-40. Review. — View Citation

Brunk D. Injection of Candida antigen works on warts. Skin and Allergy News. 1999; 30(12):5.

Horn TD, Johnson SM, Helm RM, Roberson PK. Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial. Arch Dermatol. 2005 May;141(5):589-94. — View Citation

Johnson SM, Brodell RT. Treating warts: a review of therapeutic options. Consultant 1999;39(1):253-266.

Johnson SM, Roberson PK, Horn TD. Intralesional injection of mumps or Candida skin test antigens: a novel immunotherapy for warts. Arch Dermatol. 2001 Apr;137(4):451-5. — View Citation

Majewski S, Jablonska S. Human papillomavirus-associated tumors of the skin and mucosa. J Am Acad Dermatol. 1997 May;36(5 Pt 1):659-85; quiz 686-8. Review. — View Citation

MASSING AM, EPSTEIN WL. Natural history of warts. A two-year study. Arch Dermatol. 1963 Mar;87:306-10. — View Citation

Miller DM, Brodell RT. Human papillomavirus infection: treatment options for warts. Am Fam Physician. 1996 Jan;53(1):135-43, 148-50. Review. — View Citation

Pfister H. Human papillomaviruses and skin cancer. Semin Cancer Biol. 1992 Oct;3(5):263-71. Review. — View Citation

Quan MB, Moy RL. The role of human papillomavirus in carcinoma. J Am Acad Dermatol. 1991 Oct;25(4):698-705. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Resolution of Injected Wart	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.	Initial visit to completion of protocol, which is up to 30 weeks	No
Secondary	Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart	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.	Initial visit to completion of protocol, which is up to 30 weeks	No
Secondary	Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart	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.	Initial visit to completion of protocol, which is up to 30 weeks	No