This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Clostridium botulinum toxin type A
Chung-Ang University Hospital
Seoul, Gwangjin-gu, South Korea
Konkuk University Hospital
Seoul, Gwangjin-gu, South Korea
Nowon Eulji Medical Center
Seoul, Nowon-gu, South Korea
Primary Outcome Measure : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the improvement rate of brow wrinkles at 4 weeks after the administration of protoxin week and the improvement rate at the time of raising at 4 weeks after the administration of protoxin week in this extended clinical trial are compared and evaluated.
Time frame: 4 weeks post injection compared to baseline
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the improvement rate of brow wrinkles at 8, 12, and 16 weeks after the administration of protoxin week is compared with the improvement rate of brow wrinkles at 8, 12, and 16 weeks after the administration of protoxin week in this extended clinical trial.
Time frame: Week 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), we compare the improvement rate of normal brow wrinkles according to the tester's field evaluation at 4, 8, 12, and 16 weeks after the protoxin injection with the usual brow wrinkles according to the tester's field evaluation at 4, 8, 12, and 16 weeks after the protoxin injection in this extended clinical trial.
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the improvement rate of normal brow wrinkles is compared with the improvement rate of normal brow wrinkles at 4, 8, 12, and 16 weeks after the administration of protoxin in this extended clinical trial.
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
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In the phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the rate of improvement of brow wrinkles at 4, 8, 12, and 16 weeks after Botox week administration and the rate of improvement of brow wrinkles at 4, 8, 12, and 16 weeks after protoxin week administration in this extended clinical trial are compared and evaluated.
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the proportion of test subjects satisfied in the satisfaction assessment of test subjects at 4, 8, 12, and 16 weeks after the administration of protoxin in this extended clinical trial is compared with the proportion of test subjects satisfied in the satisfaction assessment of test subjects at 4, 8, 12, and 16 weeks after the administration of protoxin.
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In Phase 3 of PT\_B, comparing the proportion of subjects satisfied in the satisfaction assessment of subjects at week 4, 8, 12, and 16 after the main administration of PT\_P3\_21 (clinical trial plan number), and the proportion of subjects satisfied in the satisfaction assessment of subjects at week 4, 8, 12, and 16 after the main administration of protoxin, in this extended clinical trial.
Time frame: Week 4, 8, 12, 16