A Double-Blind, Split-Face, Randomized Study on the Effects and Safety of Intradermal Injection of Botulinum Toxin A (Incobotulinum Toxin A) in the Cheek
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Background: Intradermal injection of botulinum toxin A (BTXA) is used for cosmetic pur-poses without strong evidence for clinical use, as opposed to intramuscular injection. Objective: To evaluate the efficacy and safety of intradermal injection of incobotulinumtoxin A (iBTXA) in the cheeks. Methods: We conducted a study with 18 volunteers who received intradermal injectionof iBTXA into one cheek and normal saline into the contralateral side as a control. Vol-unteers visited the clinic at weeks 2, 4, 8, and 12 after injection. At each visit, pores andwrinkles were evaluated by a facial analyzer, sebum secretion by a sebumeter, skin textureby both volunteers and clinicians, and wrinkles of the nasolabial fold were graded withphotographic reviews. Results: There were no significant effects on the wrinkles of the infraorbital area and se-bum secretion. However, there were significant improvements in the wrinkles of the naso-labial fold and skin texture on the iBTXA injected side. The effects on the wrinkles of thenasolabial fold lasted 12 weeks, and those on skin texture lasted 8 weeks. Improvement inthe pore size was observed only at week 2. No serious adverse events were reported exceptone volunteer who complained of facial palsy after the injection of 30 units of iBTXA inone cheek. However, injection of 20 units of iBTXA in one cheek was not associated withany adverse events. Conclusion: Intradermal injection of iBTXA, could provide clinical benefits for skin tex-ture and wrinkles overcoming the skin prick effect without obvious side effects.
Abstract
Background: Intradermal injection of botulinum toxin A (BTXA) is used for cosmetic pur-poses without strong evidence for clinical use, as opposed to intramuscular injection. Objective: To evaluate the efficacy and safety of intradermal injection of incobotulinumtoxin A (iBTXA) in the cheeks. Methods: We conducted a study with 18 volunteers who received intradermal injectionof iBTXA into one cheek and normal saline into the contralateral side as a control. Vol-unteers visited the clinic at weeks 2, 4, 8, and 12 after injection. At each visit, pores andwrinkles were evaluated by a facial analyzer, sebum secretion by a sebumeter, skin textureby both volunteers and clinicians, and wrinkles of the nasolabial fold were graded withphotographic reviews. Results: There were no significant effects on the wrinkles of the infraorbital area and se-bum secretion. However, there were significant improvements in the wrinkles of the naso-labial fold and skin texture on the iBTXA injected side. The effects on the wrinkles of thenasolabial fold lasted 12 weeks, and those on skin texture lasted 8 weeks. Improvement inthe pore size was observed only at week 2. No serious adverse events were reported exceptone volunteer who complained of facial palsy after the injection of 30 units of iBTXA inone cheek. However, injection of 20 units of iBTXA in one cheek was not associated withany adverse events. Conclusion: Intradermal injection of iBTXA, could provide clinical benefits for skin tex-ture and wrinkles overcoming the skin prick effect without obvious side effects.
참고문헌 (24)
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