Volume 16, Issue 3 (Volume 16, No 3 2025)
jdc 2025, 16(3): 139-147 |
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Samadi A, Nassiri Kashani M, Ayatollahi A, Zartab H, Ahmadi M, Firooz A. Comparison of the efficacy and safety of three Iran-made botulinum toxin type A products in improving moderate
to severe glabellar lines. jdc 2025; 16 (3) :139-147
URL: http://jdc.tums.ac.ir/article-1-5807-en.html
URL: http://jdc.tums.ac.ir/article-1-5807-en.html
Aniseh Samadi1 
, Mansour Nassiri Kashani1 , Azin Ayatollahi1 , Hamed Zartab1 , Maryam Ahmadi1 , Alireza Firooz *2
, Mansour Nassiri Kashani1 , Azin Ayatollahi1 , Hamed Zartab1 , Maryam Ahmadi1 , Alireza Firooz *2
1- Clinical Evaluation Laboratory for Pharmaceutical, Cosmetic and Hygienic Products (DermaLab), Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
2- Clinical Evaluation Laboratory for Pharmaceutical, Cosmetic and Hygienic Products (DermaLab), Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran ,firozali@tums.ac.ir
2- Clinical Evaluation Laboratory for Pharmaceutical, Cosmetic and Hygienic Products (DermaLab), Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran ,
Abstract: (451 Views)
Background and aim: In recent years, increasing demand for aesthetic treatments in Iran and the need for high-quality domestic products have encouraged several companies to produce botulinum toxin type A. This study aimed to evaluate and compare the clinical efficacy and safety of three such Iranian products.
Methods: In the first part of the study, the overall efficacy of the botulinum toxin type A products for treating glabellar lines was assessed in 230 participants who received one of the three Iranian formulations (mean age 42.69 ± 9.21 years), and compared with 230 participants who received the standard treatment (Dysport®) (mean age 42.50±9.79 years). Outcomes were evaluated on day 30 post-injection. In the second part, the comparative efficacy of the three domestic products during the same period and their safety profile up to month four post-injection were assessed.
Results: A clinically meaningful response (at least a two-grade improvement in glabellar line severity) was achieved in 68.6% of recipients of the Iranian products, compared with 52.8% of Dysport recipients, demonstrating a statistically significant superiority in equivalence studies (P<0.01). Among the three domestic products, only product No. 2 showed a significantly higher proportion of participants achieving ≥2-grade improvement (assessed by an independent physician). The type and frequency of adverse events (except for headache) were comparable to the standard drug monograph.
Conclusion: The findings indicate acceptable efficacy and safety of Iran-made botulinum toxin type A products compared with the reference product. Except for limited differences, the efficacy and safety profiles of the three formulations were generally similar up to day 30 post-injection.
Methods: In the first part of the study, the overall efficacy of the botulinum toxin type A products for treating glabellar lines was assessed in 230 participants who received one of the three Iranian formulations (mean age 42.69 ± 9.21 years), and compared with 230 participants who received the standard treatment (Dysport®) (mean age 42.50±9.79 years). Outcomes were evaluated on day 30 post-injection. In the second part, the comparative efficacy of the three domestic products during the same period and their safety profile up to month four post-injection were assessed.
Results: A clinically meaningful response (at least a two-grade improvement in glabellar line severity) was achieved in 68.6% of recipients of the Iranian products, compared with 52.8% of Dysport recipients, demonstrating a statistically significant superiority in equivalence studies (P<0.01). Among the three domestic products, only product No. 2 showed a significantly higher proportion of participants achieving ≥2-grade improvement (assessed by an independent physician). The type and frequency of adverse events (except for headache) were comparable to the standard drug monograph.
Conclusion: The findings indicate acceptable efficacy and safety of Iran-made botulinum toxin type A products compared with the reference product. Except for limited differences, the efficacy and safety profiles of the three formulations were generally similar up to day 30 post-injection.
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