PHN - Post-Herpetic NeuritisPhase 2/3PHNNCT07599800
A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
A Phase 2/3 study testing APC101 in people with PHN - Post-Herpetic Neuritis, run by Andros Pharmaceuticals Co., Ltd. at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PHN - Post-Herpetic Neuritis
- What is being tested?
- APC101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2026to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
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- 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.
- 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.
- 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.
- 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:
- Baseline WAPS ≥5, as assessed using NRS-11 score in the target area. Participants with baseline WAPS <5 will be considered screen failures.
- 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.
- 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.
- 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 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.
Who cannot join
- 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.
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- 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 anesthetic 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/her unsuitable for the study in the opinion of the investigator or sponsor.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Suncoast Clinical Research
Florida City, Florida, 34652
About this study
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.
Read the detailed 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 compared with patch, which shows safer profile.
- Can be administered twice daily as needed.
- The only prescription spray product providing pain relief for PHN with clinical evidence.
This is a Phase IIb/III, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of APC101 in patients with PHN.
- Conditions
- PHN - Post-Herpetic Neuritis
- Being tested
- APC101, Control
- Keywords
- PHN, APC101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APC101Drug
Lidocaine spray 5% solution
ControlOther
A vehicle spray solution
| Study group | Role | What they receive |
|---|---|---|
| APC101 | Experimental | Lidocaine spray 5% solution Receives: Drug: APC101 |
| Control | Placebo comparator | Vehicle spray solution Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS-11
Change in the weekly average pain score* (WAPS), assessed using NRS-11.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHN - Post-Herpetic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- APC101 or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andros Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599800
- Sponsor's protocol ID
- Andros-APC101-301
- Acronym
- PHN
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb/III Clinical Study to Evaluate the Efficacy and Safety of APC101 in Patients With Postherpetic Neuralgia.
- ClinicalTrials.gov ID
- NCT07599800
- Acronym / sponsor ID
- PHN / Andros-APC101-301
- Conditions
- PHN - Post-Herpetic Neuritis
- Keywords
- PHN, APC101
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- Andros Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 compared with patch, which shows safer profile.
- Can be administered twice daily as needed.
- The only prescription spray product providing pain relief for PHN with clinical evidence.
This is a Phase IIb/III, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of APC101 in patients with PHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- APC101 or placebo.
| Arm | Type | Receives |
|---|---|---|
| APC101 | Experimental | Drug: APC101Lidocaine spray 5% solution |
| Control | Placebo comparator | Other: ControlVehicle spray solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APC101Lidocaine spray 5% solution | Drug | APC101 |
| ControlA vehicle spray solution | Other | Control |
Primary outcome
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).
Change in the weekly average pain score* (WAPS), assessed using NRS-11.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing APC101 in people with PHN - Post-Herpetic Neuritis, run by Andros Pharmaceuticals Co., Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ae-June Wang, PhD (+886-3-6581866, APC101_P3@andros.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.