計劃書編號MT14-TW24GBL303
尚未開始召募
2026-06-01 - 2028-12-31
Phase III
尚未開始4
一項多中心、雙盲、隨機、活性對照、平行分組的第三期臨床試驗，評估MBA-P01用於中度至重度皺眉紋受試者的有效性與安全性
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試驗申請者
台灣美德妥股份有限公司
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試驗委託 / 贊助單位名稱
台灣美德妥股份有限公司
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臨床試驗規模
台灣多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
適應症
中度至重度皺眉紋
試驗目的
1. Primary objective
To demonstrate non-inferiority of MBA-P01 versus Botox® for the treatment of Glabellar Lines (GL) by comparing responder rate in the investigator’s live assessment of Facial Wrinkle Scale (FWS) at 4 weeks after the treatment.
2. Secondary objective (s)
-To compare the efficacy between MBA-P01 and Botox® for the treatment of GL in participants with moderate to severe GL
-To compare the safety between MBA-P01 and Botox® for the treatment of GL in participants with moderate to severe GL
藥品名稱
注射用凍晶粉末
乾粉注射劑
乾粉注射劑
主成份
Clostridium Botulinum Toxin Type A Complex
劑型
048
240
240
劑量
100U/vial
評估指標
主持人現場依面部皺紋量表(FWS)評定治療後4週受試者眉頭緊皺時，皺眉紋嚴重程度的緩解率*
*: 主持人或獨立評分醫師依照4級距面部皺紋量表(Facial Wrinkle Scale, FWS：0=無，1=輕度，2=中度，3=重度)，評定受試者眉頭緊皺時的FWS等級。眉頭緊皺時的緩解率定義：與基線相比至少改善2等級，且FWS改變至0級(無)或1級(輕度)的受試者比例。
*: 主持人或獨立評分醫師依照4級距面部皺紋量表(Facial Wrinkle Scale, FWS：0=無，1=輕度，2=中度，3=重度)，評定受試者眉頭緊皺時的FWS等級。眉頭緊皺時的緩解率定義：與基線相比至少改善2等級，且FWS改變至0級(無)或1級(輕度)的受試者比例。
主要納入條件
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1.Male or female adults aged ≥ 18 years
2.Participants who have moderate (2) or severe (3) glabellar lines at maximum frown as assessed by the investigator using FWS at Screening
3.Voluntarily signed the approved informed consent form prior to any study-related procedures being performed
1.Male or female adults aged ≥ 18 years
2.Participants who have moderate (2) or severe (3) glabellar lines at maximum frown as assessed by the investigator using FWS at Screening
3.Voluntarily signed the approved informed consent form prior to any study-related procedures being performed
主要排除條件
An individual who meets any of the following criteria will be excluded from participation in this study:
1.History of facial nerve paralysis
2.Any eyebrow or eyelid ptosis as determined by the investigator at screening
3.Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin
4.The inability to substantially lessen glabellar lines even by physically spreading them apart (e.g., unable to smooth out the wrinkles when stretched by hand), as determined by the investigator
5.Active skin disease or infection in the treatment area
6.Any medical condition that could put a participant at increased risk due to the administration of the investigational product (e.g. diseases that may affect neuromuscular function, including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
7.Participants who received any of the following drugs within 4 weeks prior to screening:
i.Muscle relaxants: peripheral acting agents, central acting agents, directly acting agents.
ii.Benzodiazepines (BZD) and similar drugs: Diazepam, Chlordiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Alprazolam, Lorazepam, Temazepam, Clonazepam, etc.
* Participants who have been taking muscle relaxants or benzodiazepines (BZD) at a stable dose from 4 weeks prior to study entry may be enrolled.
8.Anticoagulants or antiplatelet drugs use within 7 days before the treatment (low-dose aspirin (≤ 325 mg/day) is permitted)
9.Participants who received retinoids within the specified period prior to screening:
i.3 months: On topical retinoid therapy and/or topical hormone cream applied to the upper face, who have not been on a consistent dose regimen and are unable to maintain the same regimen for the study
ii.6 months: On oral retinoid therapy
10.Participants who have received any of the following aesthetic treatments in the upper or middle face occurring within the specified period prior to screening:
i.3 months: any upper-facial nonablative resurfacing laser, light or ultrasound treatment, microdermabrasion, or superficial peels
ii.6 months: any upper-facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid [TCA] and phenol), facial resurfacing or skin tightening procedure with laser, light, or radiofrequency-based system
iii.12 months: any periorbital, mid-facial, or upper-facial treatment with non-permanent soft tissue fillers
11.Prior periorbital surgery, facial lift (full, upper face), brow lift, or related procedures (e.g., eyelid [blepharoplasty] and/or eyebrow surgery)
12.Prior facial treatment with permanent soft tissue fillers, synthetic implantation (e.g., Gore-Tex®), and/or autologous fat transplantation
13.Botulinum toxin treatment within 6 months prior to screening
14.Known immunization or hypersensitivity to any botulinum toxin preparations
15.Female participants* who are pregnant or nursing, or planning a pregnancy during the study, or confirmed to be pregnant by a pregnancy test
* All women of childbearing potential (WOCBP), except those who have been amenorrheic for a minimum of 12 months or have undergone surgical sterilization such as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, may participate in the study only if their urine pregnancy test is confirmed to be negative on treatment day.
16.Participants who are not willing to use effective contraception methods** during study participation
** Effective contraceptive methods include hormonal contraception (oral, intravaginal, transdermal, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), vasectomy, tubal ligation, male or female condom with spermicide, cervical cap, diaphragm or contraceptive sponge with spermicide, and complete abstinence.
17.Participants who are participating in other clinical study or have participated in other study within 30 days prior to screening (studies only with questionnaire or specimen collection are exemption)
18.Participants who are not eligible for this study at the discretion of the investigator
1.History of facial nerve paralysis
2.Any eyebrow or eyelid ptosis as determined by the investigator at screening
3.Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin
4.The inability to substantially lessen glabellar lines even by physically spreading them apart (e.g., unable to smooth out the wrinkles when stretched by hand), as determined by the investigator
5.Active skin disease or infection in the treatment area
6.Any medical condition that could put a participant at increased risk due to the administration of the investigational product (e.g. diseases that may affect neuromuscular function, including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
7.Participants who received any of the following drugs within 4 weeks prior to screening:
i.Muscle relaxants: peripheral acting agents, central acting agents, directly acting agents.
ii.Benzodiazepines (BZD) and similar drugs: Diazepam, Chlordiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Alprazolam, Lorazepam, Temazepam, Clonazepam, etc.
* Participants who have been taking muscle relaxants or benzodiazepines (BZD) at a stable dose from 4 weeks prior to study entry may be enrolled.
8.Anticoagulants or antiplatelet drugs use within 7 days before the treatment (low-dose aspirin (≤ 325 mg/day) is permitted)
9.Participants who received retinoids within the specified period prior to screening:
i.3 months: On topical retinoid therapy and/or topical hormone cream applied to the upper face, who have not been on a consistent dose regimen and are unable to maintain the same regimen for the study
ii.6 months: On oral retinoid therapy
10.Participants who have received any of the following aesthetic treatments in the upper or middle face occurring within the specified period prior to screening:
i.3 months: any upper-facial nonablative resurfacing laser, light or ultrasound treatment, microdermabrasion, or superficial peels
ii.6 months: any upper-facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid [TCA] and phenol), facial resurfacing or skin tightening procedure with laser, light, or radiofrequency-based system
iii.12 months: any periorbital, mid-facial, or upper-facial treatment with non-permanent soft tissue fillers
11.Prior periorbital surgery, facial lift (full, upper face), brow lift, or related procedures (e.g., eyelid [blepharoplasty] and/or eyebrow surgery)
12.Prior facial treatment with permanent soft tissue fillers, synthetic implantation (e.g., Gore-Tex®), and/or autologous fat transplantation
13.Botulinum toxin treatment within 6 months prior to screening
14.Known immunization or hypersensitivity to any botulinum toxin preparations
15.Female participants* who are pregnant or nursing, or planning a pregnancy during the study, or confirmed to be pregnant by a pregnancy test
* All women of childbearing potential (WOCBP), except those who have been amenorrheic for a minimum of 12 months or have undergone surgical sterilization such as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy, may participate in the study only if their urine pregnancy test is confirmed to be negative on treatment day.
16.Participants who are not willing to use effective contraception methods** during study participation
** Effective contraceptive methods include hormonal contraception (oral, intravaginal, transdermal, injectable, implantable), intrauterine device (IUD), intrauterine system (IUS), vasectomy, tubal ligation, male or female condom with spermicide, cervical cap, diaphragm or contraceptive sponge with spermicide, and complete abstinence.
17.Participants who are participating in other clinical study or have participated in other study within 30 days prior to screening (studies only with questionnaire or specimen collection are exemption)
18.Participants who are not eligible for this study at the discretion of the investigator
試驗計畫預計收納受試者人數
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台灣人數
274 人
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全球人數
274 人
