Clinical Trials List
Protocol NumberOBI-858-005
Active
2025-11-03 - 2027-12-31
Phase III
Recruiting8
ICD-10Z41.1
Encounter for cosmetic surgery
ICD-9V50.1
Elective surgery for other plastic surgery for unacceptable cosmetic appearance
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of OBI- 858 in Subjects with Moderate to Severe Glabellar Lines.
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Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2026/07/02
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王柏方 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭椿昱 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Sheau-Chiou Chao
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Moderate to severe frown lines
Objectives
Primary Objectives:
• To evaluate the efficacy of OBI-858 compared to placebo in the treatment of moderate to severe frown lines.
Secondary Objectives:
• To evaluate the efficacy of OBI-858.
• To evaluate the safety and tolerability of OBI-858.
• To evaluate the immunogenicity of OBI-858.
Test Drug
Freeze-dried injection
Active Ingredient
Botulinum toxin type A
Dosage Form
245
Dosage
100U/vial
Endpoints
• On day 29, the proportion of participants whose glabellar line severity score, determined by on-site assessment by both the trial physician and the participant, improved by more than 2 points.
Inclution Criteria
1. Age includes male and female adults aged 20 and above.
2. As assessed by the participating physician and the participant, the severity of frown lines must be at least grade 2 (grade 0: no frown lines, grade 1: mild, grade 2: moderate, grade 3: severe).
3. Participants must voluntarily sign a participant consent form, and as assessed by the participating physician or their authorized personnel, the participant's physical and mental condition must be suitable for participation in this trial, and they must agree to comply with the trial procedures.
2. As assessed by the participating physician and the participant, the severity of frown lines must be at least grade 2 (grade 0: no frown lines, grade 1: mild, grade 2: moderate, grade 3: severe).
3. Participants must voluntarily sign a participant consent form, and as assessed by the participating physician or their authorized personnel, the participant's physical and mental condition must be suitable for participation in this trial, and they must agree to comply with the trial procedures.
Exclusion Criteria
1. The severity of frown lines in a relaxed state is at least grade 2, as assessed by the trial physician.
2. Any medical condition in the subject that could potentially increase the risk after receiving the investigational drug (e.g., diseases that affect neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, motor neuron disease).
3. The subject has the following pre-existing medical history, as assessed by the trial physician:
a. Cirrhosis or decompensated liver disease (defined as clinical conditions such as ascites, encephalopathy, coagulation disorders, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, etc.)
b. Known active hepatitis B virus (HBV) infection (defined as HBsAg positive) at the time of screening or within six months prior to screening. (Subjects who are HBsAg negative, or HBsAg positive but with HBV DNA viral load <2000 IU/mL, and whose ALT has returned to normal for at least three months after treatment, are eligible for the trial.)
c. Subjects with known active hepatitis C virus (HCV) infection (defined as HCV RNA positive) at the time of screening or within six months prior to screening. (Subjects who have successfully received HCV treatment and whose HCV RNA viral load has been undetectable for at least six months after treatment completion are eligible for the trial.)
4. Subjects with abnormal liver or kidney function or hematological changes detected before treatment, specifically defined as follows:
a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal.
b. Total bilirubin > 2 times the upper limit of normal.
c. Platelet count ≤ 100,000/mm³
5. The subject's laboratory test results are clinically significant, as assessed by the trial physician. If a subject's laboratory test results are outside the normal range but are deemed clinically insignificant by the trial physician, the subject may participate in this trial with the physician's consent.
6. The subject has a history of facial nerve palsy or ptosis.
7. The subject has a skin disease or infection at the injection site.
8. The subject has received botulinum toxin injections at any site within the six months prior to the screening period.
9. The subject is known to have a past history of botulism or idiopathic reactions to botulinum toxin.
10. The subject has previously received botulinum toxin vaccines for any serotype.
11. The subject is known to have an allergic or idiopathic reaction to botulinum toxin products or their excipients and related components.
12. Subjects who use medications that may affect neuromuscular responses and the efficacy assessment of the investigational drug within the four weeks prior to the screening period or during the trial period, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterase agents (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
13. Subjects who, within six months prior to the screening period, received non-Botox products that, according to the investigating physician, may affect frown lines or forehead wrinkles or interfere with the injection and evaluation of the investigational drug, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency skin tightening, ultrasound skin tightening), facial resurfacing (e.g., laser resurfacing, chemical resurfacing), permanent implants, pulsed light therapy, and dermabrasion.
14. Subjects who, within 18 months prior to screening, received hyaluronic acid-based soft tissue/dermal filler treatments around the eyes, midface, or upper face.
15. Subjects who have received facelifts, permanent implants, or have scars between the eyebrows or on the forehead that may affect treatment outcomes.
16. Subjects known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
17. Subjects are expected to receive facial cosmetic procedures on the upper and middle face during the trial period that may affect treatment outcomes, including but not limited to: dermal fillers, pulsed light therapy, deep chemical peels, and dermabrasion.
18. Subjects are expected to receive treatment with any serotype of botulinum toxin product on any other body part during the trial period.
19. Subjects are pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
20. Subjects of fertility are unwilling to abstain from sexual activity for 6 months after receiving OBI-858 injections, or for their partner or themselves to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. Female subjects will be considered infertile if they meet any of the following conditions:
a. Reaching physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months. b. Six weeks after a hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
21. The subject participated in other interventional clinical trials, or ophthalmological or neurological clinical trials, within 28 days prior to receiving the investigational drug injection.
22. The subject is deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
2. Any medical condition in the subject that could potentially increase the risk after receiving the investigational drug (e.g., diseases that affect neuromuscular responses, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, motor neuron disease).
3. The subject has the following pre-existing medical history, as assessed by the trial physician:
a. Cirrhosis or decompensated liver disease (defined as clinical conditions such as ascites, encephalopathy, coagulation disorders, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, etc.)
b. Known active hepatitis B virus (HBV) infection (defined as HBsAg positive) at the time of screening or within six months prior to screening. (Subjects who are HBsAg negative, or HBsAg positive but with HBV DNA viral load <2000 IU/mL, and whose ALT has returned to normal for at least three months after treatment, are eligible for the trial.)
c. Subjects with known active hepatitis C virus (HCV) infection (defined as HCV RNA positive) at the time of screening or within six months prior to screening. (Subjects who have successfully received HCV treatment and whose HCV RNA viral load has been undetectable for at least six months after treatment completion are eligible for the trial.)
4. Subjects with abnormal liver or kidney function or hematological changes detected before treatment, specifically defined as follows:
a. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal.
b. Total bilirubin > 2 times the upper limit of normal.
c. Platelet count ≤ 100,000/mm³
5. The subject's laboratory test results are clinically significant, as assessed by the trial physician. If a subject's laboratory test results are outside the normal range but are deemed clinically insignificant by the trial physician, the subject may participate in this trial with the physician's consent.
6. The subject has a history of facial nerve palsy or ptosis.
7. The subject has a skin disease or infection at the injection site.
8. The subject has received botulinum toxin injections at any site within the six months prior to the screening period.
9. The subject is known to have a past history of botulism or idiopathic reactions to botulinum toxin.
10. The subject has previously received botulinum toxin vaccines for any serotype.
11. The subject is known to have an allergic or idiopathic reaction to botulinum toxin products or their excipients and related components.
12. Subjects who use medications that may affect neuromuscular responses and the efficacy assessment of the investigational drug within the four weeks prior to the screening period or during the trial period, including but not limited to: muscle relaxants (e.g., Tubocularine Chloride, Dantrolene Sodium, and Baclofen), antiacetylcholinesterase agents (e.g., Butylbromide and Trihexyphenidyl HCl), and aminoglycoside antibiotics (e.g., Amikacin, Tobramycin, and Gentamicin) (dermal/topical aminoglycoside antibiotics may be used with the consent of the investigating physician).
13. Subjects who, within six months prior to the screening period, received non-Botox products that, according to the investigating physician, may affect frown lines or forehead wrinkles or interfere with the injection and evaluation of the investigational drug, including but not limited to: hyaluronic acid injections, absorbable minimally invasive facelifts, skin tightening (e.g., radiofrequency skin tightening, ultrasound skin tightening), facial resurfacing (e.g., laser resurfacing, chemical resurfacing), permanent implants, pulsed light therapy, and dermabrasion.
14. Subjects who, within 18 months prior to screening, received hyaluronic acid-based soft tissue/dermal filler treatments around the eyes, midface, or upper face.
15. Subjects who have received facelifts, permanent implants, or have scars between the eyebrows or on the forehead that may affect treatment outcomes.
16. Subjects known to have had a poor response to Botox A treatment (e.g., inability to physically reduce frown lines to a satisfactory level, such as inability to smooth frown lines with hands).
17. Subjects are expected to receive facial cosmetic procedures on the upper and middle face during the trial period that may affect treatment outcomes, including but not limited to: dermal fillers, pulsed light therapy, deep chemical peels, and dermabrasion.
18. Subjects are expected to receive treatment with any serotype of botulinum toxin product on any other body part during the trial period.
19. Subjects are pregnant or breastfeeding. Female subjects of fertility must have a negative pregnancy test result at screening.
20. Subjects of fertility are unwilling to abstain from sexual activity for 6 months after receiving OBI-858 injections, or for their partner or themselves to use medically acceptable contraception.
Acceptable contraception methods include intrauterine devices (IUDs), oral contraceptives, cervical caps with spermicides, contraceptive sponges, condoms, and vasectomy, according to local regulations or guidelines. Female subjects will be considered infertile if they meet any of the following conditions:
a. Reaching physiological amenorrhea, defined as spontaneous cessation of menstruation for 6 months with plasma follicle-stimulating hormone concentrations within the amenorrhea range, or spontaneous cessation of menstruation for 12 months. b. Six weeks after a hysterectomy or bilateral salpingo-oophorectomy.
c. Bilateral tubal ligation.
21. The subject participated in other interventional clinical trials, or ophthalmological or neurological clinical trials, within 28 days prior to receiving the investigational drug injection.
22. The subject is deemed unsuitable for this trial for other reasons, as assessed by the trial physician.
The Estimated Number of Participants
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Taiwan
300 participants
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Global
300 participants
