A multicenter, double-blind, randomized, parallel-group, active-controlled, phase 3 clinical trial to compare the effectiveness and safety of two botulinum toxin type A formulations for improving moderate to severe glabellar wrinkles in Asians

Figures & data

Figure 1. A total of 20 units/0.5 ml of botulinum toxin A was injected intramuscularly in 0.1 ml at 5 points. (A) Middle of the corrugator supercilii muscle (each eyebrow line muscle). (B) Medial corrugator supercilii muscle (inner corner of each eyebrow line muscle). (C) Procerus muscle (between the eyebrows).

Table 1. The improvement rate of glabellar wrinkles at rest and expression assessed by investigators.

	Test group (BMI2006)	Control group (BOTOX^®)	p-value
N (%)	137(100)	136(100)
At rest
Week 4	29(21.17)	20(14.71)	.1642
Week 8	23(17.16)	16(11.85)	.2160
Week 12	15(11.03)	13(9.70)	.7205
Week 16	8(5.84)	9(6.77)	.7538
At expression
Week 4	108(78.83)	113(83.09)	.3706
Week 8	89(66.42)	89(65.93)	.9320
Week 12	47(34.56)	58(43.28)	.1415
Week 16	21(15.33)	28(21.05)	.2224

Figure 2. Representative photographs of changes in glabellar wrinkles before and after BMI 2006 injection. Improvement peaked at 4 weeks and gradually decreased over time but remained better than baseline.

Table 2. The improvement rate of glabellar wrinkles at rest and expression assessed by independent investigators.

	Test group (BMI2006)	Control group (BOTOX^®)	p-value
N (%)	137(100)	136(100)
At rest
Week 4	5(3.65)	2(1.47)	.4470
Week 8	4(2.99)	4(2.96)	1.0000
Week 12	3(2.21)	2(1.49)	1.0000
Week 16	4(2.92)	2(1.50)	.6842
At expression
Week 4	115(83.94)	113(83.09)	.8493
Week 8	87(64.93)	79(58.52	.2798
Week 12	45(33.09)	44(32.84)	.9648
Week 16	21(15.33)	23(17.29)	.6621

Figure 3. The percentage of glabellar wrinkles improved by 90% or more as assessed by the subject. There was no statistically significant difference between the two groups at any time point.

Figure 4. The percentage of satisfied subjects with treatment. There was no statistically significant difference between the two groups at any time point.

Data availability statement

The data that support the findings of this study are available from the corresponding author, KBJ, upon reasonable request.