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No-Touch spray could ease shingles nerve pain

NCT ID NCT07599800

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a lidocaine spray (APC101) for people with postherpetic neuralgia, a painful nerve condition after shingles. The spray delivers pain relief without touching the sensitive skin. About 333 adults will use the spray or a placebo to see if it reduces pain over 24 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lidocaine spray 5% solution
What this could lead to
If it works, this could provide a convenient, gentle way to manage nerve pain after shingles without touching the painful skin.
What could go wrong
This is an early-to-mid stage trial, so the spray may not prove more effective than a placebo. Also, lidocaine can cause skin irritation or allergic reactions in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 333 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Participants will be eligible for enrollment in the study only if they meet ALL the following inclusion criteria at the time of screening: Inclusion criteria: 1. Males or females ≥ 18 years. 2. Female of non-childbearing potential (i.e., 12 months or more of spontaneous amenorrhea without an alternative medical cause, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization,. 3. Women of childbearing potential (WOCBP) must be confirmed to be not pregnant at Screening Visit. 4. Males with sexual partners and females of childbearing potential must agree to use a highly effective contraceptive method: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * Oral * Intravaginal * Transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation: * Oral * Injectable * Implantable * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomised partner. Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP study participant and that the vasectomised partner has received medical assessment of the surgical success. * Sexual abstinence: abstinence is acceptable as a highly effective method of contraception only when it is consistent with the participant's usual and preferred lifestyle. Periodic or situational abstinence will not be considered acceptable for the purposes of meeting contraceptive requirements. Male participants should use a condom throughout the study. For a non-pregnant WOCBP partner, the highly effective contraception recommendations listed above should also be considered. Note: Birth control methods considered unacceptable in clinical trials Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together. 5. Persistent pain for lasting \> 3 months from the appearance of herpes zoster rash that is not located in proximity to mucous membranes. 6. Diagnosis of PHN based on medical history as judged by investigator. 7. Persistent neuropathic pain that involves at least one dermatome and covers ≤420 cm2. 8. If the participant has been on stable dose(s) of oral analgesic medication(s) for at least 30 days prior to the Screening Visit, they need to be willing to maintain the respective dose(s) and medication throughout the study. 9. Pain intensity score (NRS-11 score) in the target area of ≥ 5 at Screening Visit (Visit 1), and meeting all of the following conditions at Visit 2 (Day 1), prior to randomization: 1. Baseline WAPS ≥5, as assessed using NRS-11 score in the target area. Participants with baseline WAPS \<5 will be considered screen failures. 2. Participants who report an NRS-11 score \<5 on ≤ 1 occasion. Participants who report an NRS-11 score \<5 on ≥ 2 occasions within a week will be considered screen failures. 3. Participants with evaluable WAPS, i.e., with WAPS records of ≥4 out of 7 data points collected during the Run-in period. Participants with WAPS records of \<4 out of 7 data points during the Run-in period will be considered screen failures. 10. Skin is intact over the painful area to be treated. 11. Able and willing to provide informed consent and comply with study procedures. 12. In the opinion of the investigator, the PHN-affected area to be administered study drug will allow adequate contact of the study drug with the skin without affecting any mucous membranes. Participants meeting ANY of the following exclusion criteria at the time of Screening will not be able to participate in this study. Exclusion criteria: 1. Participant has systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study as judged by the investigator. 2. Participant has a history of human immunodeficiency virus, hepatitis C, or hepatitis B. 3. Participant has a history of malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years. 4. Participant has a history of mental illness or psychiatric illness, such as dementia, depression, or schizophrenia, that can limit his/her ability to comply with study procedures as judged by the investigator. 5. Participant is unable to apply, or to have a caregiver apply, the study spray to the most painful skin segments twice a day as directed. 6. Participant has known sensitivity to lidocaine-containing products. 7. Participant has active herpes zoster lesions or dermatitis. 8. Participant has other condition(s) that cause severe or chronic pain that may impair the self-assessment of the pain due to PHN as judged by the investigator. 9. Participant has been treated in the area of PHN with a local anesthetic within 14 days prior to Run-in period or has had a nerve block within 30 days prior to Run-in period. 10. Participant is receiving or plans to receive any prohibited medication or therapy for the duration of the study, or is unable to washout these medications or therapies prior to Run-in period. 11. Participant has used capsaicin patches within 90 days prior to Run-in period or has used other capsaicin preparations daily in the 90 days prior to Run-in period. 12. Pregnant or lactating females. 13. Participant has an active history of alcohol or drug abuse. 14. Participant has participated in any other investigational study within 30 days prior to Screening Visit. 15. Participant or participant's direct family is employed by the sponsor or study staff. 16. Participant has any condition that would make him/her unsuitable for the study in the opinion of the investigator or sponsor.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Suncoast Clinical Research

    Florida City, Florida, 34652, United States

  • University of Sunshine Cost

    Brisbane, Queensland, 4117, Australia