Study With Candida Antigen for Treatment of Warts

NCT00569231 | Completed Phase 1 Results

• 1 other identifier: 46487
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Warts; HPV

Keywords

Warts; Candida; HPV; Injections, Intralesional; Immune System

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart

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

• Number of Participants With Clinical Resolution of 2nd Anatomically Distant, Non-injected Wart

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

Other Outcomes (1)

• Number of Participants With Immune Response to Human Papillomavirus Type 57 (HPV-57) L1-peptide

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

Study Arms (1)

Candida Antigen

EXPERIMENTAL

Drug: Candida Antigen

Interventions

Candida Antigen DRUG

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.

Also known as: Candin

Candida Antigen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• Allermed Laboratories, Inc.: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (11)

• 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. doi: 10.1016/s0190-9622(97)80315-5.

  PMID: 9146528 BACKGROUND

• Baker GE, Tyring SK. Therapeutic approaches to papillomavirus infections. Dermatol Clin. 1997 Apr;15(2):331-40. doi: 10.1016/s0733-8635(05)70441-1.

  PMID: 9098642 BACKGROUND

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

  PMID: 8546041 BACKGROUND

• Quan MB, Moy RL. The role of human papillomavirus in carcinoma. J Am Acad Dermatol. 1991 Oct;25(4):698-705. doi: 10.1016/0190-9622(91)70256-2.

  PMID: 1665155 BACKGROUND

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

  PMID: 1335790 BACKGROUND

• MASSING AM, EPSTEIN WL. Natural history of warts. A two-year study. Arch Dermatol. 1963 Mar;87:306-10. doi: 10.1001/archderm.1963.01590150022004. No abstract available.

  PMID: 13933441 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11295925 BACKGROUND

• 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. doi: 10.1001/archderm.141.5.589.

  PMID: 15897380 BACKGROUND

• Coleman HN, Greenfield WW, Stratton SL, Vaughn R, Kieber A, Moerman-Herzog AM, Spencer HJ, Hitt WC, Quick CM, Hutchins LF, Mackintosh SG, Edmondson RD, Erickson SW, Nakagawa M. Human papillomavirus type 16 viral load is decreased following a therapeutic vaccination. Cancer Immunol Immunother. 2016 May;65(5):563-73. doi: 10.1007/s00262-016-1821-x. Epub 2016 Mar 15.

  PMID: 26980480 DERIVED

MeSH Terms

Conditions

Warts; Torulopsis

Interventions

PRA1 protein, Candida albicans

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: Mayumi Nakagawa, MD, PhD
• Organization: University of Arkansas for Medical Sciences

mnakagawa@uams.edu

(501) 686-8635

Study Officials

• Mayumi Nakagawa, MD, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 25, 2011
• Results First Posted: January 25, 2011

Record last verified: 2010-12

Locations

US (1)