Candin for Common Warts

Recruiting at 18 trial locations

Overseen By Nielsen Central Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Nielsen BioSciences, Inc.

Must not be taking: Immunotherapy, Immunosuppressives

Disqualifiers: Immune compromise, Keloid history, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: Up to 20 weeks

330 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but you cannot take certain treatments like immunotherapy, immunosuppressive drugs, or specific wart treatments within certain timeframes before and during the study.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those that affect the immune system, like immunosuppressive drugs, within 6 months before starting the trial and during the study. If you're on treatments like immunotherapy or certain wart treatments, you need to stop them 12 weeks before the trial.

What data supports the idea that Candin for Common Warts is an effective treatment?

The available research shows that Candin, when used as a treatment for common warts, has been effective for many patients. In one study, 80% of the 100 patients treated with Candin responded positively, with 39% experiencing complete removal of their warts and 41% showing partial improvement. This suggests that Candin can be a successful option for treating warts. Additionally, the treatment was generally well-tolerated with minimal side effects. Compared to other treatments, Candin has shown promising results, especially in cases where other methods might not work as well. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Candin for common warts?

Research shows that injecting Candida antigen into warts can be effective, with 80% of patients responding to the treatment, including those with weakened immune systems. This treatment works by boosting the body's immune response to fight the warts. ^{1 2 3 4 5}

What safety data exists for Candin treatment for warts?

The safety of Candin, a Candida albicans skin test antigen, has been evaluated in various studies. One study found that the 1-microgram dose of the antigen was effective and safe for recall antigen skin tests, with only one adverse reaction reported in an atopic subject. Another study indicated that the antigen is not irritating to neonatal skin, suggesting its safety. Additionally, intralesional immunotherapy using Candin in combination with other antigens was found to be safe and effective for treating warts, with 71% of subjects experiencing resolution of their warts. ^{3 6 7 8 9}

Is Candin safe for use in humans?

Candin, used as a skin test antigen, has been generally safe in humans, with only one reported adverse reaction in a person with a specific allergy. The safety profile of Candin compares well with other similar skin test antigens. ^{3 6 7 8 9}

Is Candin a promising drug for treating common warts?

Candin, a skin test product made from Candida albicans, shows potential as a treatment because it can effectively trigger an immune response. This response might help the body fight off common warts, making Candin a promising option. ^{6 7 8 9 10}

How does the treatment Candin for common warts differ from other treatments?

Candin is unique because it uses a skin test antigen derived from Candida albicans to stimulate the immune system, which is different from typical wart treatments that often involve topical acids or cryotherapy (freezing). This approach leverages the body's immune response to target the warts, offering a novel mechanism compared to standard treatments. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to compare outcome in healthy subjects 12 years of age and older with at least 3, but no more than 20, common warts (Verruca vulgaris) following treatment with Candin or placebo. The main questions it aims to answer are: * does treatment with Candin result in better clearance of warts than placebo * how many injections are required to result in wart clearance Participants will * have one wart selected for injection every two weeks until clearance * return 12 weeks after wart clearance for assessment of durability of response

Eligibility Criteria

This trial is for healthy individuals aged 12 and older who have between 3 to 20 common warts. Participants must be willing to use contraception during the study.

Inclusion Criteria

I have between 3 and 20 common warts.

Willing to agree to use adequate contraception methods during the study

Exclusion Criteria

Candin delayed type hypersensitivity reaction test wheal sized < 5 mm or > 25 mm at the Baseline Visit

History of keloid formation

I have not been treated for a Candida albicans infection in the last 12 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of Candin or placebo every 2 weeks into a single treatment wart until clearance or up to 10 injections

Up to 20 weeks

Bi-weekly visits for injections

Observational

Participants are monitored for 12 weeks after wart clearance to assess the durability of response

12 weeks

Final visit at 12 weeks post-clearance

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Candin

Trial Overview The trial tests if Candin, an intradermal solution, is more effective at clearing common warts than a placebo. Patients will receive injections in one wart every two weeks until it clears and will return after 12 weeks post-clearance for follow-up.

Participant Groups

Group I: Candin treatment Experimental Treatment 1 Intervention

Candida albicans Skin Test Antigen for Cellular Hypersensitivity will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections

Group II: Placebo Placebo Group 1 Intervention

Matching placebo (sterile saline) will be administered as a 0.5 mL injection at the region of the interdigitated base of the treatment wart (epidermal/dermal junction) every 2 weeks for up to 10 injections

Candin is already approved in United States for the following indications:

Approved in United States as CANDIN for:

• Assess cellular hypersensitivity to Candida albicans

Who Is Running the Clinical Trial?

Nielsen BioSciences, Inc.

Lead Sponsor

Trials

5

Recruited

780+

Findings from Research

In a retrospective study of 100 patients treated with intralesional Candida antigen for common warts, 80% showed a positive response, with 39% achieving complete clearance and 41% showing partial improvement.

The treatment was well-tolerated with minimal side effects, and it was effective even in immunocompromised patients, suggesting it could be a viable option for a challenging dermatological issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Candida antigen injections for the treatment of verruca vulgaris: A two-year mayo clinic experience. Alikhan, A., Griffin, JR., Newman, CC.[2018]

A new adverse reaction to Candida albicans antigen immunotherapy was observed in a patient, presenting as pain, swelling, and a purple hue in the distal index finger after treatment for warts.

This reaction is believed to be caused by a vigorous delayed-type hypersensitivity response, leading to edema and potential vascular compromise, highlighting the need for awareness among physicians using this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The painful purple digit: an alarming complication of Candida albicans antigen treatment of recalcitrant warts. Perman, M., Sterling, JB., Gaspari, A.[2013]

In a study involving patients with warts, a combination of Candida albicans, mumps, and Trichophyton skin test antigens led to a 71% resolution rate of warts, indicating its efficacy.

The study suggests that using a combination of antigens may be as safe as single antigen injections while potentially enhancing treatment outcomes for wart removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional immunotherapy for warts using a combination of skin test antigens: a safe and effective therapy. Johnson, SM., Horn, TD.[2022]

In a study of 220 children treated with intralesional injection of Candida antigen for warts, 70.9% achieved complete resolution, demonstrating its efficacy as a treatment option.

The treatment was found to be safe, with only mild discomfort reported during injections and no serious side effects, making it a suitable alternative for children with difficult-to-treat warts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional Candida Antigen Immunotherapy for the Treatment of Recalcitrant and Multiple Warts in Children. Muñoz Garza, FZ., Roé Crespo, E., Torres Pradilla, M., et al.[2015]

Candida skin testing reagents can significantly enhance T-cell proliferation in healthy subjects, indicating a robust immune response that may help in regressing warts.

The study identified that the mechanism involves the stimulation of Langerhans cells, leading to increased production of the cytokine IL-12, which promotes Th1 immune responses, suggesting a targeted approach to enhance anti-HPV T-cell activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-12 secretion by Langerhans cells stimulated with Candida skin test reagent is mediated by dectin-1 in some healthy individuals. Nakagawa, M., Coleman, HN., Wang, X., et al.[2022]

In guinea pigs, contact sensitivity to Candida albicans was successfully induced through patch testing, showing that even non-immune animals can develop a reaction after exposure, indicating a potential mechanism for delayed hypersensitivity.

In humans, a strong correlation was found between delayed hypersensitivity reactions to intradermally injected C. albicans antigen and positive patch-test reactions, suggesting that the Candida patch test could be a useful tool for assessing immune function in patients with skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact sensitivity to Candida albicans--comparative studies in man and animal (guinea-pig). Tagami, H., Urano-Suehisa, S., Hatchome, N.[2019]

In a study involving 100 individuals, the yeast cell suspension antigen showed a slightly higher positive response (69.0%) compared to the polysaccharide antigen (61.0%) in intradermal tests for delayed hypersensitivity to Candida albicans.

Despite the differences in positivity rates, there was a high concordance of 82.0% between the two antigens, suggesting that the polysaccharide antigen is also a viable option for testing immunological cellular competence against Candida albicans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Candidin: comparison of two antigens for cutaneous delayed hypersensitivity testing. Fava-Netto, C., Gambale, W., Croce, J., et al.[2019]

In a case series of 78 pediatric patients, Candin, a standardized Candida albicans skin test, demonstrated a response rate of 64%, which is comparable or superior to older nonstandardized tests.

Candin was found to be safe, with no adverse events reported, and it is particularly effective when used alongside other antigens to assess cellular immunity, especially in infants and immunocompromised patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric case series evaluating a standardized Candida albicans skin test product. Ohri, LK., Manley, JM., Chatterjee, A., et al.[2004]

A new skin test antigen derived from Candida albicans (CASTA) was developed and found to be safe for use in skin tests, with only one notable adverse reaction in a highly sensitive individual out of the tested subjects.

In a study involving 40 healthy subjects, the CASTA skin test demonstrated a significant reactor rate of 50% at a 1-microgram dose, indicating its potential effectiveness in measuring cell-mediated immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel Candida albicans skin test antigen: efficacy and safety in man. Esch, RE., Buckley, CE.[2020]

The study identifies that abnormal delayed-type hypersensitivity to Candida albicans is linked to specific circulating T cells, particularly CD8 cells, which can be detected through cell culture after intradermal injection of the antigen.

There is a strong correlation between clinical symptoms, skin tests, and lymphocyte activation tests, suggesting that these methods can help diagnose this difficult-to-detect immune response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of delayed type hypersensitivity to Candida albicans. Evaluation of lymphocyte activation by flow cytometry (171 observations)]. Brunet, JL., Gozon, G., Sainte-Laudy, J., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of Candida antigen injections for the treatment of verruca vulgaris: A two-year mayo clinic experience. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The painful purple digit: an alarming complication of Candida albicans antigen treatment of recalcitrant warts. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Intralesional immunotherapy for warts using a combination of skin test antigens: a safe and effective therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intralesional Candida Antigen Immunotherapy for the Treatment of Recalcitrant and Multiple Warts in Children. [2015]

5. England pubmed.ncbi.nlm.nih.gov

IL-12 secretion by Langerhans cells stimulated with Candida skin test reagent is mediated by dectin-1 in some healthy individuals. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Contact sensitivity to Candida albicans--comparative studies in man and animal (guinea-pig). [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Candidin: comparison of two antigens for cutaneous delayed hypersensitivity testing. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Pediatric case series evaluating a standardized Candida albicans skin test product. [2004]

9. England pubmed.ncbi.nlm.nih.gov

A novel Candida albicans skin test antigen: efficacy and safety in man. [2020]

10. France pubmed.ncbi.nlm.nih.gov

[Diagnosis of delayed type hypersensitivity to Candida albicans. Evaluation of lymphocyte activation by flow cytometry (171 observations)]. [2017]