A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
Andros Pharmaceuticals Co., Ltd.
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.
Description
APC101 is a film-forming, sustained-release, and metered-dose topical spray. This investigational product (IP) is formulated with 5% by weight of lidocaine and several excipients. APC101 offers several unique properties or advantages over the first line topical treatment of lidocaine patches, including: * Can be applied to the area above the neck (face and head). * Contact-free: eliminating pain when apply to the skin of PHN patients. * Suitable to apply to uneven skin of PHN patient. * Less adverse reactions such as skin rash and redness at the application sites. * Less systemic absorption c…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAPC101
Lidocaine spray 5% solution
- OtherControl
A vehicle spray solution
Locations (2)
- Suncoast Clinical ResearchFlorida City, Florida
- University of Sunshine CostBrisbane, Queensland