Clinical trial · Interventional
Study With Candida Antigen for Treatment of Warts
A Phase 1 Study to Evaluate the Immunologic Mechanisms Underlying Wart Resolution After Intralesional Immunotherapy With Candida Antigen
NCT00569231CI-TRIAL-00004343completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV | — | UNRESOLVED | — |
| Warts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Candida Antigen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Candida Antigen
- interventionNames
- Drug: Candida Antigen
Primary outcomes (1)
- measure
- Number of Participants With Clinical Resolution of Injected Wart
- timeFrame
- Initial visit to completion of protocol, which is up to 30 weeks
- description
- 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.
Secondary outcomes (2)
- measure
- Number of Participants With Clinical Resolution of 1st Anatomically Distant, Non-injected Wart
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDMajewski 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
- BACKGROUNDBaker 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
- BACKGROUNDMiller DM, Brodell RT. Human papillomavirus infection: treatment options for warts. Am Fam Physician. 1996 Jan;53(1):135-43, 148-50. PMID 8546041
- BACKGROUNDQuan 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
- BACKGROUNDPfister H. Human papillomaviruses and skin cancer. Semin Cancer Biol. 1992 Oct;3(5):263-71. PMID 1335790
- BACKGROUNDMASSING 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
- BACKGROUNDJohnson SM, Brodell RT. Treating warts: a review of therapeutic options. Consultant 1999;39(1):253-266.
- BACKGROUNDBrunk D. Injection of Candida antigen works on warts. Skin and Allergy News. 1999; 30(12):5.
- BACKGROUNDJohnson 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
- BACKGROUNDHorn 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.