Candin for Common Warts

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Candin, an injection, can clear common warts more effectively than a placebo (a harmless substance with no therapeutic effect). Participants will receive injections every two weeks until their warts disappear, and the study will also monitor how long the warts remain clear. It is designed for individuals with 3 to 20 common warts. As a Phase 3 trial, this study represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Candin, a skin test derived from the yeast Candida albicans, is generally safe. Studies have found that injecting this yeast into a wart can help the immune system combat it, making it a common and safe treatment option. The FDA has approved Candin for testing immune response, indicating its safety is well understood.

In one study, researchers used Candin safely in doses up to 0.3 mL for several months, supporting its use for treating warts. While no treatment is entirely risk-free, existing data shows that Candin is well-tolerated with few reported side effects. Participants in earlier studies experienced minimal adverse effects, suggesting Candin is a potentially safe option for wart treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for common warts, which typically involve topical solutions or cryotherapy to remove the wart tissue, Candin uses a unique approach. It leverages the body's immune system by injecting Candida albicans Skin Test Antigen directly into the wart, aiming to stimulate a cellular immune response that targets the wart itself. Researchers are excited about Candin because this method could offer a more effective and less invasive option for patients, potentially reducing recurrence rates and offering a more targeted treatment.

What evidence suggests that Candin might be an effective treatment for common warts?

Research suggests that Candin, a treatment using a substance from the Candida albicans yeast, might help eliminate common warts. Previous studies have shown that Candin can activate the body's immune system to combat the virus causing warts. Some patients saw their warts disappear after receiving Candin injections. In this trial, participants will receive either Candin injections or a placebo to evaluate its effectiveness. However, Candin has not yet been proven safe and effective specifically for treating warts. More studies are needed to confirm these results. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12033141/

Randomized Phase IIa Trial of Purified Candida Antigen for ... This study assessed three dosing schemes using Candin®, a standardized purified Candida antigen (PCA), for the treatment of common warts.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01757392

Candin Safety & Efficacy Study for the Treatment of Warts The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly ...

3. thedermdigest.com thedermdigest.com/enrollment-complete-for-phase-3-trial-of-candin-for-the-treatment-of-common-warts/

Enrollment Complete for Phase 3 Trial of Candin ... The study is a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of Candin (Candida albicans Skin Test Antigen for Cellular ...

4. biospace.com biospace.com/press-releases/nielsen-biosciences-successfully-completes-enrollment-into-phase-3-trial-of-candin-for-the-treatment-of-common-warts

Nielsen BioSciences Successfully Completes Enrollment ... The study is a Phase 3, randomized, double-blind, placebo-controlled study of the safety and efficacy of CANDIN (Candida albicans Skin Test ...

5. nielsenbio.com nielsenbio.com/news/

News Candida albicans Skin Test Antigen for Cellular Hypersensitivity has not been proven safe and effective for use in warts. Nielsen BioSciences intends to pursue ...

6. nielsenbio.com nielsenbio.com/candin-hcp/

CANDIN - Candida Albicans Skin Test Antigen for Cellular ... CANDIN is the only Candida albicans extract-based skin testing antigen for intradermal injection licensed by the FDA to assess cell-mediated hypersensitivity ...

7. fda.gov fda.gov/media/97965/download

Package Insert - CANDIN CANDIN® is a skin test antigen to assess cellular hypersensitivity to Candida albicans. •. The product should not be used to diagnose or treat Type 1 allergy ...