A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Pos… (NCT07599800) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
United States, Australia333 participantsStarted 2026-08-01
Plain-language summary
APC101 is developed to provide continuous lidocaine administration over 24 hours and is safe when administered to intact skin. Dispensing from a metered-dose spray pump, APC101 provides once or twice daily flexible dosing options that deliver medication without physically touching the afflicted allodynic skin site, resulting in very light, minimal contact with the painful, hypersensitive skin affected by PHN.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females ≥ 18 years.
. 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,.
. Women of childbearing potential (WOCBP) must be confirmed to be not pregnant at Screening Visit.
. Males with sexual partners and females of childbearing potential must agree to use a highly effective contraceptive method:
. Persistent pain for lasting \> 3 months from the appearance of herpes zoster rash that is not located in proximity to mucous membranes.
. Diagnosis of PHN based on medical history as judged by investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NRS-11
Timeframe: From baseline (Week -1; within 7 days ending on the date of randomization) to the evaluation conducted within 7 days ending on the date of the end of treatment (EOT).
. Persistent neuropathic pain that involves at least one dermatome and covers ≤420 cm2.
. 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.
Exclusion criteria
. 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.
. Participant has a history of human immunodeficiency virus, hepatitis C, or hepatitis B.
. Participant has a history of malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years.
. 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.
. 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.
. Participant has known sensitivity to lidocaine-containing products.
. Participant has active herpes zoster lesions or dermatitis.
. 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.