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WartsPhase 1NCT00569231

Study With Candida Antigen for Treatment of Warts

A Phase 1 study testing Candida Antigen in people with Warts and HPV, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Warts, HPV
What is being tested?
Candida Antigen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Feb 2007to Jan 2010
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Warts, HPV
Being tested
Candida Antigen
Keywords
Warts, Candida, HPV, Injections, Intralesional, Immune System
Medical subject headings
Warts, Torulopsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Candida AntigenDrug

    Also called Candin

    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.

Study groups in NCT00569231
Study groupRoleWhat they receive
Candida AntigenExperimentalNot described
Receives: Drug: Candida Antigen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569231
Sponsor's protocol ID
46487
Status last verified
Dec 2010
First submitted
6 Dec 2007
Last updated
25 Jan 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 9146528

  • 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.

    PubMed 9098642

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

    PubMed 8546041

  • 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.

    PubMed 1665155

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

    PubMed 1335790

  • 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.

    PubMed 13933441

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

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

  • 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.

    PubMed 11295925

  • 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.

    PubMed 15897380

  • 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.

    PubMed 26980480

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Candida Antigen in people with Warts and HPV, run by University of Arkansas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Resolution of Injected Wart (time frame: Initial visit to completion of protocol, which is up to 30 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569231, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.

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