APC101 for Shingles

(PHN Trial)

Not yet recruiting at 1 trial location

Overseen By Ae-June Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Andros Pharmaceuticals Co., Ltd.

Must be taking: Oral analgesics

Must not be taking: Local anesthetics, Capsaicin

Disqualifiers: Systemic disease, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new lidocaine spray called APC101, designed to ease pain from shingles (specifically postherpetic neuralgia, or PHN) by applying it directly to the skin without touching the sore spots. The goal is to determine if APC101 can safely relieve pain over 24 hours with minimal contact. Individuals with persistent pain for more than three months since their shingles rash and intact skin in the affected area might be suitable candidates. The trial compares the lidocaine spray against a placebo (a non-active spray solution) to evaluate its effectiveness. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important medical advancements.

Is there any evidence suggesting that APC101 is likely to be safe for humans?

Research has shown that APC101, a lidocaine spray, is generally well-tolerated by people with postherpetic neuralgia. Although specific side effects are not detailed, lidocaine is a widely used local anesthetic in many medical treatments, indicating general safety. The trial's progression to Phase 2 and Phase 3 means APC101 has passed initial safety tests in humans. This suggests the treatment is likely safe enough for further study, though individual reactions may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for shingles?

Unlike other treatments for shingles that typically involve oral antiviral medications like acyclovir or valacyclovir, APC101 offers a new approach with its lidocaine spray 5% solution. Lidocaine is a topical anesthetic, and its use in a spray form allows for direct application to the painful areas, potentially providing faster and more localized pain relief. Researchers are excited about APC101 because it could offer a non-systemic treatment option that minimizes side effects commonly associated with oral medications, while also addressing the pain associated with shingles more effectively.

What evidence suggests that APC101 might be an effective treatment for shingles?

Research has shown that lidocaine, the main ingredient in APC101, helps relieve pain from shingles. It works by blocking nerve signals, which can reduce pain. Studies have found that lidocaine patches significantly lessen pain in people with postherpetic neuralgia (PHN), a common shingles complication. In this trial, participants may receive APC101, which delivers lidocaine as a spray, aiming to provide similar pain relief without direct contact with the painful skin. This spray method allows for flexible dosing and is gentle on sensitive skin areas. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with postherpetic neuralgia (nerve pain that lasts after shingles). Participants should have painful, sensitive skin from shingles and be able to use a topical spray. People with broken or damaged skin at the treatment site may not qualify.

Inclusion Criteria

I am a woman who cannot become pregnant due to menopause or surgery.

I am a woman of childbearing age and not pregnant.

I am able to take medications by mouth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive APC101 or placebo spray for postherpetic neuralgia

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• APC101

Trial Overview

The study tests APC101, a lidocaine spray applied once or twice daily to relieve nerve pain from shingles. It compares APC101 to a control group in terms of effectiveness and safety.

How Is the Trial Designed?

Group I: APC101 Experimental Treatment 1 Intervention

Lidocaine spray 5% solution

Group II: Control Placebo Group 1 Intervention

Vehicle spray solution

Who Is Running the Clinical Trial?

Andros Pharmaceuticals Co., Ltd.

Lead Sponsor

Citations

1.

shingrixhcp.com

shingrixhcp.com/efficacy-safety/efficacy-data/

SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)

EFFICACY AGAINST SHINGLES BY AGE IN ADULTS ≥50 YEARS OLD ; 50-59 years old · 96.6%. (95% CI: 89.6, 99.3). 3 (3492). 87 (3525) ; 60-69 years old · 97.4%. (95% CI: ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33580242/

Real-World Effectiveness in the First 2 Years Post-Licensure

Results: We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6-71.5) and 56.9% (95% CI, 55.0-58.8) for 2 and 1 doses, ...

3.

cidrap.umn.edu

cidrap.umn.edu/varicella/study-estimates-74-efficacy-shingles-vaccine-patients-over-50

Study estimates 74% efficacy of shingles vaccine in ...

Two doses of the adjuvanted recombinant shingles vaccine (Shingrix) are an estimated 74% effective against herpes zoster infection and 84% effective against ...

4.

vaccineadvisor.com

vaccineadvisor.com/news/shingrix-vaccine-50-effective-in-inflammatory-arthritis/

Shingrix Vaccine Reduces Herpes Zoster Risk By 50% in ...

Among patients with inflammatory arthritis, receipt of the Shingrix vaccine is associated with a 50% reduction in herpes zoster incidence.

5.

shingrixhcp.com

shingrixhcp.com/home-ic/efficacy-safety/efficacy-data/

Efficacy Data | SHINGRIX (Zoster Vaccine Recombinant, ...

SHINGRIX demonstrated strong efficacy in immunocompromised patients ≥18 years of age.1 SHINGRIX Demonstrated 68.2% Efficacy Against Herpes Zoster in auHSCT ...

6.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK441824/

Herpes Zoster - StatPearls - NCBI Bookshelf

Herpes simplex, CMV, EBV, and human herpesviruses have all been found in patients with shingles. Go to: History and Physical. Zoster characteristically presents ...

7.

cdc.gov

cdc.gov/shingles/hcp/clinical-overview/index.html

Clinical Overview of Shingles (Herpes Zoster)

Shingles complications include postherpetic neuralgia, hearing or vision loss, encephalitis, and pneumonia. The signs and symptoms of herpes ...

8.

anzctr.org.au

anzctr.org.au/Trial/Registration/TrialReview.aspx?id=24964&isClinicalTrial=True

ANZCTR - Registration

... Safety of APC101 in Patients With Postherpetic Neuralgia. ... Persistent pain for lasting > 3 months from the appearance of herpes zoster rash ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05371080

NCT05371080 | A Study on the Long-term Efficacy, Safety ...

... Results Data Element definitions for more information ... Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults.