Clinical Trials List
Protocol NumberAndros-APC101-101
Active
2024-03-31 - 2026-06-30
Phase II
Recruiting3
ICD-10B02.22
Postherpetic trigeminal neuralgia
ICD-9053.12
Postherpetic trigeminal neuralgia
A Phase II clinical study to evaluate the efficacy and safety of APC101 in patients with Postherpetic Neuralgia over the head and neck
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Trial Applicant
T-TOP Clinical Research Co., Ltd.
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Sponsor
Andros Pharmaceuticals Co., Ltd
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Cheng-Che Lan Division of Dermatology
- 盧奕丞 Division of Anesthesia
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Shu-Ping Chao
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Postherpetic Neuralgia over the head and neck
Objectives
Primary Objective:
Assess the change in pain score from baseline on day 22 after twice-daily APC101 administration using the Numerical Rating Scale for Pain (NRS-11).
Secondary Objectives:
• Assess the change in pain and quality of life scores over time from baseline after APC101 administration using the NRS-11, the Neuropathic Pain Symptom Scale (NPSI), the Randomized Occurrence of Life Questionnaire (RAND-36), and the Pain and Sleep Questionnaire (PSQ-3).
• Assess the proportion of subjects whose NRS-11 and NPSI scores improved after APC101 administration.
• Assess the safety of APC101 (including local skin tolerability).
Test Drug
spary
Active Ingredient
LIDOCAINE
Dosage Form
405
Dosage
5%
Endpoints
Change from Baseline at Day 22 in NRS-11
Inclution Criteria
1. Adult men and women aged 18 years and older.
2. Men, infertile women (e.g., spontaneous amenorrhea for 12 months or more, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy and bilateral oophorectomy at least 6 months prior to randomization, or for women aged 50 years and older, hysterectomy (without bilateral oophorectomy) at least 6 months prior to randomization), or fertile women who have not become pregnant (to be confirmed at screening).
3. Men with sexual partners or women of fertility potential must agree to use an effective method of contraception (abstinence, birth control pills, IUDs or patches, diaphragms, intrauterine devices, condoms, sterilization, vasectomy, or progesterone implantation or injection) from screening to the end of the trial and for one month after withdrawal from the trial.
4. Subjects who have experienced postherpetic neuralgia (PHN) for at least 3 months after healing from herpes zoster on the head and neck.
5. Persistent neuropathic pain involving at least one dermatome and an area not exceeding 420 cm².
6. If the subject has been taking a stable dose of oral analgesic for at least 30 days prior to the screening visit, they must be willing to maintain the same medication type and dosage throughout the trial to participate.
7. The Numerical Rating Scale (NRS-11) pain intensity score for the target area must be >4 at both the screening visit (SV) and the first treatment visit (TV1). If the subject's pain intensity score is ≤4 at the first treatment visit, a reassessment may be conducted the following day.
8. The skin at the site of pain to be treated in the target area is intact.
9. The subject is able and willing to provide consent and adhere to the trial procedures.
10. The trial administrator believes that the affected target area allows for sufficient skin contact with the test drug without affecting any mucosal tissue.
2. Men, infertile women (e.g., spontaneous amenorrhea for 12 months or more, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy and bilateral oophorectomy at least 6 months prior to randomization, or for women aged 50 years and older, hysterectomy (without bilateral oophorectomy) at least 6 months prior to randomization), or fertile women who have not become pregnant (to be confirmed at screening).
3. Men with sexual partners or women of fertility potential must agree to use an effective method of contraception (abstinence, birth control pills, IUDs or patches, diaphragms, intrauterine devices, condoms, sterilization, vasectomy, or progesterone implantation or injection) from screening to the end of the trial and for one month after withdrawal from the trial.
4. Subjects who have experienced postherpetic neuralgia (PHN) for at least 3 months after healing from herpes zoster on the head and neck.
5. Persistent neuropathic pain involving at least one dermatome and an area not exceeding 420 cm².
6. If the subject has been taking a stable dose of oral analgesic for at least 30 days prior to the screening visit, they must be willing to maintain the same medication type and dosage throughout the trial to participate.
7. The Numerical Rating Scale (NRS-11) pain intensity score for the target area must be >4 at both the screening visit (SV) and the first treatment visit (TV1). If the subject's pain intensity score is ≤4 at the first treatment visit, a reassessment may be conducted the following day.
8. The skin at the site of pain to be treated in the target area is intact.
9. The subject is able and willing to provide consent and adhere to the trial procedures.
10. The trial administrator believes that the affected target area allows for sufficient skin contact with the test drug without affecting any mucosal tissue.
Exclusion Criteria
1. The trial administrator determines that the subject has a systemic disease that may pose additional risks or limit their ability to participate in the trial.
2. The subject has a history of HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
3. The subject has a history of malignancy other than carcinoma in situ within the past two years.
4. The subject has a mental illness or a history of mental illness, such as dementia, depression, or schizophrenia, which, in the trial administrator's judgment, may affect their ability to adhere to the trial procedures.
5. The subject is unable to apply the spray to the target site twice daily as instructed, and there is no caregiver to assist with administration.
6. The subject is allergic to products containing lidocaine.
7. The subject is currently suffering from shingles or dermatitis.
8. The trial administrator determines that other conditions causing severe or chronic pain may affect the subject's self-assessment of postherpetic neuralgia.
9. The subject received local anesthetic treatment in the area of neuropathic pain within 14 days prior to the first treatment visit, or underwent nerve block surgery within 30 days prior to the first treatment visit.
10. The subject is currently receiving any drugs/treatments prohibited under the protocol and cannot wash out the effects of these drugs or treatments before the screening visit.
11. The subject used capsaicin patches or other capsaicin preparations daily within 90 days prior to the first treatment visit.
12. The subject is pregnant or breastfeeding.
13. The subject has a history of or is currently abusing alcohol or drugs.
14. The subject participated in other clinical trials within 30 days prior to the screening visit.
15. The subject or their immediate family member is employed by a sponsor or trial personnel.
16. The trial administrator or sponsor believes the subject is unsuitable for participation in this trial.
2. The subject has a history of HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
3. The subject has a history of malignancy other than carcinoma in situ within the past two years.
4. The subject has a mental illness or a history of mental illness, such as dementia, depression, or schizophrenia, which, in the trial administrator's judgment, may affect their ability to adhere to the trial procedures.
5. The subject is unable to apply the spray to the target site twice daily as instructed, and there is no caregiver to assist with administration.
6. The subject is allergic to products containing lidocaine.
7. The subject is currently suffering from shingles or dermatitis.
8. The trial administrator determines that other conditions causing severe or chronic pain may affect the subject's self-assessment of postherpetic neuralgia.
9. The subject received local anesthetic treatment in the area of neuropathic pain within 14 days prior to the first treatment visit, or underwent nerve block surgery within 30 days prior to the first treatment visit.
10. The subject is currently receiving any drugs/treatments prohibited under the protocol and cannot wash out the effects of these drugs or treatments before the screening visit.
11. The subject used capsaicin patches or other capsaicin preparations daily within 90 days prior to the first treatment visit.
12. The subject is pregnant or breastfeeding.
13. The subject has a history of or is currently abusing alcohol or drugs.
14. The subject participated in other clinical trials within 30 days prior to the screening visit.
15. The subject or their immediate family member is employed by a sponsor or trial personnel.
16. The trial administrator or sponsor believes the subject is unsuitable for participation in this trial.
The Estimated Number of Participants
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Taiwan
21 participants
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Global
21 participants
