Not Yet RecruitingPhase 2Phase 3ACTRN12625001044415

A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients with Postherpetic Neuralgia.

Sponsor

Andros Pharmaceuticals Pty Ltd

Enrollment

333 participants

Start Date

Jul 1, 2026

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

The primary purpose of this study is to evaluate the clinical efficacy and safety of topical lidocaine spray in reducing neuropathic pain is superiority in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo spray.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria15

Males or females are greater than or equal to 18 years.
Female of non-childbearing potential (i.e., 12 months or more of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization).
Females of childbearing potential must be confirmed to be not pregnant at screening.
Males with sexual partners and females of childbearing potential must agree to use an effective contraceptive method (abstinence, birth control pills, rings or patches, diaphragm, intrauterine device, condom, surgical sterilization, vasectomy, progestin implant or injection) from screening to the end of study, and for 1 month after exiting the study.
Persistent pain for more than 3 months from the appearance of herpes zoster rash that is not located on the face or in proximity to mucous membranes.
Diagnosis of Postherpetic Neuralgia (PHN) based on medical history as judged by investigator.
Persistent neuropathic pain that involves at least one dermatome and covering no more than 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.
Pain intensity score (NRS-11 score) in the target area of greater than or equal to 5 at Screening visit (Visit 1), and meeting all of the following conditions at Visit 2 (Day 1), prior to randomization:
a. Baseline Weekly Average Pain Score (WAPS) greater than or equal to 5, as assessed using NRS-11 score in the target area. For participants whose baseline Weekly Average Pain Score (WAPS) is less than 5, they will be considered screen failures.
b. Participants who report an NRS-11 score of less than 5 on less than or equal to one occasion. Participants who report an NRS-11 score of less than 5 on two or more occasions within a week will be considered screen failures.
c. Participants with evaluable Weekly Average Pain Score (WAPS), i.e., with Weekly Average Pain Score (WAPS) records of at least 4 out of 7 data points collected during the Run-in period. Participants with Weekly Average Pain Score (WAPS) records of less than 4 out of 7 data points during the Run-in period will be considered screen failures.
Skin is intact over the painful area to be treated.
Able and willing to provide informed consent and comply with study procedures.
In the opinion of the Investigator, the Postherpetic Neuralgia (PHN) area affected to be administered study drug will allow adequate contact of the study drug with the skin without affecting any mucous membranes.

Exclusion Criteria16

Participant has systemic disease that would put him or her at an additional risk or limit his or 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, which can limit his/her ability to comply with study procedures as judged by the investigator.
Participant is unable to apply, or have a caregiver to apply, 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.
Participant has been treated in the area of PHN with a local anaesthetic within 14 days prior to Run-in period or has had a nerve block within 30 days prior to Run-in period.
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.
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.
Pregnant or lactating females.
Participant has an active history of alcohol or drug abuse.
Participant has participated in any other investigational study within 30 days prior to Screening visit.
Participant or participant’s direct family is employed by the sponsor or study staff.
Participant has any condition that would make him or her unsuitable for the study in the opinion of the investigator or sponsor.

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Interventions

Lidocaine spray 5% solution applied topically to intact skin twice a day, for treatment of maximum 28 days. The IP adherence will be monitored by bottle return and weight the bottle by scale, and al

Lidocaine spray 5% solution applied topically to intact skin twice a day, for treatment of maximum 28 days. The IP adherence will be monitored by bottle return and weight the bottle by scale, and also the participant will have to record the use of IP on a diary card. Total Area of Application: The IP should be applied to the most painful total marked area of up to 420 cm2. 1.If the pain area is less than and equal to 140 cm², apply 6 sprays per application; 2.if the pain area is between 141 cm² and 280 cm², apply 12 sprays per application; 3.if the pain area is between 281 cm² and 420 cm², apply 18 sprays per application.