A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
Part of paid clinical trials in Florida City, Florida.
- Sponsor
- Andros Pharmaceuticals Co., Ltd.
- Study ID
- NCT07599800
- Phase
- PHASE2/PHASE3
- Status
- Not Yet Recruiting
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Conditions
- PHN - Post-Herpetic Neuritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- APC101 — DRUGLidocaine spray 5% solution
- Control — OTHERA vehicle spray solution
Study Details
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.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 333 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: APC101Lidocaine spray 5% solution
- Placebo Comparator: ControlVehicle spray solution
Primary Outcome Measure
NRS-11 [ Time Frame: 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). ]
Central Contacts
- Ae-June Wang, PhD+886-3-6581866
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Suncoast Clinical Research | Florida City | Florida | 34652 | - |