Clinical Trials List
Protocol NumberOBI-858-003
Active
2025-03-01 - 2027-08-31
Phase II
Recruiting5
ICD-10Z41.1
Encounter for cosmetic surgery
ICD-9V50.1
Elective surgery for other plastic surgery for unacceptable cosmetic appearance
A Phase 2, multicenter, multiple-dose, monotherapy study to evaluate the safety of OBI-858 in participants with moderate to severe glabellar lines.
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Sponsor
OBIGEN Pharma
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- Yu-Huei Huang Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YI-HUA LIAO Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Shu-Hung Huang
Co-Principal Investigator
- 陳威宇 Division of Plastic Surgery
- 張兆瑋 Division of Plastic Surgery
- HSIAO-CHEN LEE
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Moderate to severe glabellar lines
Objectives
Primary Objective:
• To evaluate the safety of repeated injections of OBI-858.
Secondary Objectives:
• To evaluate the efficacy of repeated injections of OBI-858.
• To evaluate the immunogenicity of repeated injections of OBI-858.
Test Drug
OBI-858
Active Ingredient
BOTULINUM TOXIN TYPE A
Dosage Form
245
Dosage
100U/vial
Endpoints
The number of participants experiencing adverse events (AEs), serious adverse events (SAEs), or adverse events of special interest (AESIs), as well as the number of participants with clinically significant abnormalities in laboratory test results, from Day 1 through Day 365.
Inclution Criteria
Male and female adults aged 20 years or older.
At least moderate (Grade 2) glabellar line severity at maximum frown, as assessed by both the investigator and the participant (grading scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe).
Participant has voluntarily signed the informed consent form and, in the opinion of the investigator or authorized personnel, is in suitable physical and psychological condition to participate in the study and willing to comply with all study procedures.
At least moderate (Grade 2) glabellar line severity at maximum frown, as assessed by both the investigator and the participant (grading scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe).
Participant has voluntarily signed the informed consent form and, in the opinion of the investigator or authorized personnel, is in suitable physical and psychological condition to participate in the study and willing to comply with all study procedures.
Exclusion Criteria
The severity of glabellar lines at rest is Grade 2, as assessed by the investigator.
Participants with any medical condition that may increase the risk after injection of the investigational product (e.g., neuromuscular disorders such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or motor neuron disease).
Participants with clinically significant internal medical conditions (e.g., cardiovascular, respiratory, or endocrine disorders), as determined by the investigator.
Participants with clinically significant abnormalities in laboratory test results, as determined by the investigator. Participants whose results are outside the normal range but are judged by the investigator to be not clinically significant may be included.
Participants with a history of facial nerve palsy or ptosis.
Participants with skin disease or infection at the injection site.
Participants who have received botulinum toxin injections within 6 months prior to screening.
Participants with a known history of botulism or idiosyncratic hypersensitivity to botulinum toxin.
Participants who have received any botulinum toxin vaccine against any serotype.
Participants with known allergy or hypersensitivity to botulinum toxin products, their excipients, or related components.
Participants who, within 4 weeks prior to screening or who are expected to use during the study, take medications that may affect neuromuscular transmission or interfere with the evaluation of the study drug’s efficacy, including but not limited to:
– Muscle relaxants (e.g., tubocurarine chloride, dantrolene sodium, baclofen)
– Anticholinergic agents (e.g., butylbromide, trihexyphenidyl HCl)
– Aminoglycoside antibiotics (e.g., amikacin, tobramycin, gentamicin)
Topical or dermatological aminoglycosides may be allowed with investigator approval.
Participants who have received non-botulinum toxin aesthetic treatments that may affect glabellar or forehead lines within 6 months prior to screening, including but not limited to: hyaluronic acid fillers, absorbable thread lifting, radiofrequency or ultrasound skin tightening, laser resurfacing, chemical peels, permanent implants, or intense pulsed light therapy.
Participants with a history of facelift, permanent implants, or scarring between the eyebrows or on the forehead that could interfere with study outcomes.
Participants with a known poor response to botulinum toxin type A, defined as failure to achieve satisfactory wrinkle reduction (e.g., inability to manually smooth the glabellar lines).
Participants who are expected to undergo facial aesthetic procedures during the study that could affect treatment results (e.g., fillers, intense pulsed light therapy, deep chemical peels, dermabrasion).
Participants who are expected to receive any botulinum toxin treatment of any serotype during the study period.
Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test at screening.
Women of childbearing potential who are unwilling to abstain from sexual intercourse or use medically acceptable contraception for at least 6 months after OBI-858 injection.
Acceptable contraceptive methods (per local regulations or guidelines) include: intrauterine device, oral contraceptives, diaphragm with spermicide, contraceptive sponge, condom, or vasectomy of the male partner.
Women will be considered not of childbearing potential if they meet any of the following:
a. Postmenopausal, defined as natural menopause for ≥6 months with FSH levels within the postmenopausal range, or natural menopause for ≥12 months.
b. Hysterectomy or bilateral salpingo-oophorectomy at least 6 weeks prior.
c. Bilateral tubal ligation.
Participation in another clinical trial within 28 days prior to injection of the study drug.
Participants deemed unsuitable for study participation for any other reason, as determined by the investigator.
Participants with any medical condition that may increase the risk after injection of the investigational product (e.g., neuromuscular disorders such as myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or motor neuron disease).
Participants with clinically significant internal medical conditions (e.g., cardiovascular, respiratory, or endocrine disorders), as determined by the investigator.
Participants with clinically significant abnormalities in laboratory test results, as determined by the investigator. Participants whose results are outside the normal range but are judged by the investigator to be not clinically significant may be included.
Participants with a history of facial nerve palsy or ptosis.
Participants with skin disease or infection at the injection site.
Participants who have received botulinum toxin injections within 6 months prior to screening.
Participants with a known history of botulism or idiosyncratic hypersensitivity to botulinum toxin.
Participants who have received any botulinum toxin vaccine against any serotype.
Participants with known allergy or hypersensitivity to botulinum toxin products, their excipients, or related components.
Participants who, within 4 weeks prior to screening or who are expected to use during the study, take medications that may affect neuromuscular transmission or interfere with the evaluation of the study drug’s efficacy, including but not limited to:
– Muscle relaxants (e.g., tubocurarine chloride, dantrolene sodium, baclofen)
– Anticholinergic agents (e.g., butylbromide, trihexyphenidyl HCl)
– Aminoglycoside antibiotics (e.g., amikacin, tobramycin, gentamicin)
Topical or dermatological aminoglycosides may be allowed with investigator approval.
Participants who have received non-botulinum toxin aesthetic treatments that may affect glabellar or forehead lines within 6 months prior to screening, including but not limited to: hyaluronic acid fillers, absorbable thread lifting, radiofrequency or ultrasound skin tightening, laser resurfacing, chemical peels, permanent implants, or intense pulsed light therapy.
Participants with a history of facelift, permanent implants, or scarring between the eyebrows or on the forehead that could interfere with study outcomes.
Participants with a known poor response to botulinum toxin type A, defined as failure to achieve satisfactory wrinkle reduction (e.g., inability to manually smooth the glabellar lines).
Participants who are expected to undergo facial aesthetic procedures during the study that could affect treatment results (e.g., fillers, intense pulsed light therapy, deep chemical peels, dermabrasion).
Participants who are expected to receive any botulinum toxin treatment of any serotype during the study period.
Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test at screening.
Women of childbearing potential who are unwilling to abstain from sexual intercourse or use medically acceptable contraception for at least 6 months after OBI-858 injection.
Acceptable contraceptive methods (per local regulations or guidelines) include: intrauterine device, oral contraceptives, diaphragm with spermicide, contraceptive sponge, condom, or vasectomy of the male partner.
Women will be considered not of childbearing potential if they meet any of the following:
a. Postmenopausal, defined as natural menopause for ≥6 months with FSH levels within the postmenopausal range, or natural menopause for ≥12 months.
b. Hysterectomy or bilateral salpingo-oophorectomy at least 6 weeks prior.
c. Bilateral tubal ligation.
Participation in another clinical trial within 28 days prior to injection of the study drug.
Participants deemed unsuitable for study participation for any other reason, as determined by the investigator.
The Estimated Number of Participants
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Taiwan
200 participants
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Global
200 participants
