A double-blind, split-face, randomized study on the effects and safety of intradermal injection of Botulinum toxin A in the cheek

( Dong Min Shin ),( Jongeun Lee ),( Hyungrye Noh ),( Dongwhi Jang ),( Se Jin Oh ),( Ji-hye Park ),( Dongyoun Lee ),( Joo-heung Lee ),( Jong Hee Lee ) 대한피부과학회 2021 대한피부과학회 학술발표대회집 Vol.73 No.1

Background: Intradermal injection of botulinum toxin A (BTXA) is used for cosmetic purposes without strong evidence for clinical use, as opposed to intramuscular injection. Objectives: To evaluate the efficacy and safety of intradermal injection of BTXA in the cheeks. Methods: We conducted a study with 15 volunteers who received intradermal injection of BTXA into one cheek and normal saline into the contralateral side as a control. Volunteers visited the clinic at weeks 2, 4, 8, and 12 after injection. At each visit, pores and wrinkles were evaluated by a facial analyzer, sebum secretion by a sebumeter, skin texture by both volunteers and clinicians, and wrinkles of the nasolabial fold were graded with photographic reviews. Results: There were no significant effects of BTXA on the wrinkles of the infraorbital area and sebum secretion. However, there were significant improvements in the wrinkles of the nasolabial fold and skin texture on the side injected with BTXA. The effects on the wrinkles of the nasolabial fold lasted 12 weeks, and those on skin texture lasted 8 weeks. Improvement in the size of the pores was observed only at week 2. Conclusion: Intradermal injection of BTXA could provide clinical benefits for skin texture and wrinkles.

Intradermal Injection of Botulinum Toxin: A Safer Treatment Modality for Forehead Wrinkles

( Ji-young Jun ),( Ji-hye Park ),( Choon Shik Youn ),( Jong Hee Lee ) 대한피부과학회 2018 Annals of Dermatology Vol.30 No.4

Intramuscular injection of botulinum toxin A (BTXA) is commonly used for the treatment of forehead wrinkles. In practice, physicians often use an intradermal injection for this purpose, as they feel that there is a lower risk of adverse effects compared with intramuscular injection. However, there are no direct comparative studies between those two injection modalities. We conducted a 24-week long, double- blinded, split-face, pilot study of three participants to compare the efficacy and safety of intradermal or intramuscular injection of BTXA for the treatment of forehead wrinkles. Maximum improvement of wrinkles and the time to achieve maximum effect were similar for both methods. The brow level was lower on the intramuscular injection side throughout the follow-up period for all participants. Subjective satisfaction with wrinkles was similar on both sides, but patients felt more heaviness of the eyebrow on the intramuscular side. No serious side effects were noted. In conclusion, the anti-wrinkle effect of BTXA was not significantly different between intramuscular and intradermal injections. However, side effects such as eyebrow ptosis, and heaviness were more prominent after intramuscular injection. (Ann Dermatol 30(4) 458∼461, 2018)

TS 1-5 : A double-blind, split-face, randomized study on the effects and safety of intradermal injection of Botulinum toxin A in the cheek

( Dong Min Shin ),( Jongeun Lee ),( Hyungrye Noh ),( Dongwhi Jang ),( Se Jin Oh ),( Ji-hye Park ),( Dongyoun Lee ),( Joo-heung Lee ),( Jong Hee Lee ) 대한피부과학회 2021 대한피부과학회 학술발표대회집 Vol.73 No.-

Background: Intradermal injection of botulinum toxin A (BTXA) is used for cosmetic purposes without strong evidence for clinical use, as opposed to intramuscular injection. Objectives: To evaluate the efficacy and safety of intradermal injection of BTXA in the cheeks. Methods: We conducted a study with 15 volunteers who received intradermal injection of BTXA into one cheek and normal saline into the contralateral side as a control. Volunteers visited the clinic at weeks 2, 4, 8, and 12 after injection. At each visit, pores and wrinkles were evaluated by a facial analyzer, sebum secretion by a sebumeter, skin texture by both volunteers and clinicians, and wrinkles of the nasolabial fold were graded with photographic reviews. Results: There were no significant effects of BTXA on the wrinkles of the infraorbital area and sebum secretion. However, there were significant improvements in the wrinkles of the nasolabial fold and skin texture on the side injected with BTXA. The effects on the wrinkles of the nasolabial fold lasted 12 weeks, and those on skin texture lasted 8 weeks. Improvement in the size of the pores was observed only at week 2. Conclusion: Intradermal injection of BTXA could provide clinical benefits for skin texture and wrinkles.

Intradermal Injection of HA filler

( Jongseo Kim ) 대한피부과학회 2016 대한피부과학회 학술발표대회집 Vol.68 No.2

Background: Stabilized hyaluronic acid (S-HA) used for soft-tissue augmentation1 but S-HA can also be used for dermal hydration². Based on various papers which deal with the dermal hydration or ‘Skin-Booster’, the injection amount per one injection site into dermis was more than 0.02cc using particle type S-HA (Restylane Vital^TM)². However that amount which is more than 0.02cc per injection site, could cause lumps on dermis of face because diameter of 0.02cc is more than 1mm and thickness of facial dermis is less than 1mm. Some doctors believe the deep injection into sub-dermis could prevent the lumps but that deep injections does not improve skin texture efficiently². Volumizing filler injection can treat some wrinkles but it is defferent from improving skin texture. In this regard, I developed my own injection method using S-HA for improvement of skin texture in 2009. I injected 1cc of particle type S-HA dividing 1000 shots into facial dermis using injector. Key point of my method is reducing amount of injection per one injection site and that method would prevent lumps on dermis. When using injector, it also provides easier and faster injection than manual injection. Some non-particle type (mono-phasic or poly-phasic) S-HA do not make lump after injection into dermis because mono-phasic S-HA with lower cohesivity such as Belotero soft^TM or Neuramis soft^TM and Ivoire soft^TM can easily spread out from the injection points as study of some papers^3,4. But their longevity using mono-phasic S-HA is too shorter than particle type S-HA. For patients who have thin skins to improve skin texture, I prefer to inject with mono-phasic HA(Belotero basicTM, Berotero Soft^TM, Ivoire soft^TM, Neuramis soft^TM) to prevent making lumps on the dermis than particle type S-HA. Methods: Most patients had been injected with 1cc of S-HA (Restylane Vital^TM) into 1000 injection sites by injector. I did 200 stroke using injector and there are 5 needles on the part of needle head, therefore technically I injected into 1000 injection sites. Some women who have thin skin had been injected with 1cc of mono-phasic HA by injector to prevent making lump. The changes of skin texture were studied by skin roughness and morphology, dermal hydration by electric resistance, dermal thickness by ultrasonic image and biopsy study. Results: Skin roughness was significantly improved after 1000 shots of intradermal injection using 1cc of particle type S-HA. The amount of each shots was 0.001cc. Skin texture was surprisingly improved after 4 weeks intradermal injection of particle type S-HA. (Fig. 1) The changes or improvement about skin roughness could be found more easily and early by microscope than by naked eye. The depth that I injected by injector was exactly dermis in my biopsy. Conclusions: The skin texture improved after the intra-dermal injection of S-HA. Deep injection could make only replacing volume and could not make improvement of skin texture. It is recommended to use injector for dermal injection, since it would be much easier to inject than manual method for performing 1000 shots of 0.001cc. It will be faster and easy with automatic injector that can control injection amount and injection depth into dermis. This injection method that I developed with the injector will be helpful for many doctors and could make reproducibility even for beginners. In the microscopic view, even only 0.001cc of S-HA was not a small amount for dermal layer though many papers of Galderma describe the proper amount for dermal injection was about 0.02cc. Monophasic filler like Berotero Soft^TM, Ivoire soft^TM, Neuramis soft^TM and Juvederm^TM can be used with variable amount without risk of making lumps because that S-HA can spread out well as biopsy study of many paper5. But Restylane Vital^TM is hard to spread because the particle size is composed with 200 to 400 micron particles, therfore that lumps can last longer more 6 months in dermis. I found out each 0.001cc amount of Restylane Vital^TM that was made by injector last more than 13 months in my biopsy. The injection amount into each injection sites during ‘Skin-Booster’ procedure should be changed to prevent making lumps on the dermis in manual of Galderma company and papers. When using particle type S-HA, small amount about 0.001cc per one injection site can be useful for skin hydration and ‘Skin-Booster’ without making visible lumps.

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

신동민,이종은,노형래,장동휘,오세진,박지혜,이종희 대한피부과학회 2022 Annals of Dermatology Vol.34 No.6

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.

Effects of Injection Depth and Volume of Stabilized Hyaluronic Acid in Human Dermis on Skin Texture, Hydration, and Thickness

김종서 대한미용성형외과학회 2014 Archives of Aesthetic Plastic Surgery Vol.20 No.2

Background Stabilized hyaluronic acid (S-HA) is used for soft tissue augmentation and can also be used for dermal hydration. According to previous reports, the injection volume of each shot is more than 0.02 cc for dermal hydration. Clinically, this is an excessive amount for this purpose, so I will introduce a modified method using particle type S-HA injection for dermal hydration. Methods One hundred fifty patients who had 1000 injections of 1 cc S-HA by injector were analyzed. The patients were examined after 1, 2, 6, 12, and 24 months. Changes in skin texture were determined with regard to skin roughness and morphology, dermal hydration by electric resistance, dermal thickness by ultrasonic imaging, and biopsy. An intra-individual study was also performed to compare changes in skin texture between dermal and subdermal injections. Results Skin roughness significantly improved after this procedure. Electric resistance also decreased. The dermis of the face and hand were thickened about 4% after dermal injection. The injection depth was confirmed by biopsy. There were no significant changes in dermal thickness after subdermal injection with S-HA, which merely replaced fluid volume. Injections into the dermis changed both skin texture and thickness. Conclusions Skin texture was improved after 1000 dermal injections (0.001 cc each) of particle type S-HA. Deeper injections only replaced the fluid volume and could not improve skin texture. For this purpose, the use of an injector or mesogun is recommended.

Rejuvenating Effects of Facial Hydrofilling using Restylane Vital

Lee, Bong Moo,Han, Dong Gil,Choi, Won Seok Korean Society of Plastic and Reconstructive Surge 2015 Archives of Plastic Surgery Vol.42 No.3

Background Morphological changes that accompany aging, such as wrinkles and skin laxity, are particularly prominent on facial skin. Recently, facial rejuvenation using the hydrofilling effect of hyaluronic acid (HA) filler has been employed for improvement of skin texture. In this study, we studied rejuvenating effects of stabilized HA (Restylane Vital) through direct intradermal injections. Methods A total of 30 female patients underwent a series of procedures on face, including three sessions at intervals of four weeks. A total of 2 mL of Restylane Vital was injected along the whole face using an automatic injector. Improvement of skin surface roughness, elasticity, brightness, moisture, and fine wrinkles was evaluated. Patient satisfaction was evaluated, and pictures of patients were taken at each visit and 6 months after last treatment session. Scoring for each patient was performed by three doctors according in five subjects. Moisture, oil and elasticity were measured before the procedure and before the last treatment in 10 patients. Results The majority of patients (77%) were satisfied with the therapeutic outcomes. Approximately 66% of patients responded that the effects of this procedure persisted for longer than four months, and the majority of patients (77%) wanted to undergo this procedure again and would recommend this procedure to acquaintances. Regarding doctors' evaluation, scores for improvement of skin surface roughness, elasticity, and brightness were significantly higher than those for improvement of moisture and fine wrinkle. Conclusions Intradermal injection of HA can have a rejuvenating effect on dry and tired facial skin, especially in improvement of skin surface roughness.

Rejuvenating Effects of Facial Hydrofilling using Restylane Vital

이봉무,한동길,최원석 대한성형외과학회 2015 Archives of Plastic Surgery Vol.42 No.3

Background Morphological changes that accompany aging, such as wrinkles and skin laxity, are particularly prominent on facial skin. Recently, facial rejuvenation using the hydrofilling effect of hyaluronic acid (HA) filler has been employed for improvement of skin texture. In this study, we studied rejuvenating effects of stabilized HA (Restylane Vital) through direct intradermal injections. Methods A total of 30 female patients underwent a series of procedures on face, including three sessions at intervals of four weeks. A total of 2 mL of Restylane Vital was injected along the whole face using an automatic injector. Improvement of skin surface roughness, elasticity, brightness, moisture, and fine wrinkles was evaluated. Patient satisfaction was evaluated, and pictures of patients were taken at each visit and 6 months after last treatment session. Scoring for each patient was performed by three doctors according in five subjects. Moisture, oil and elasticity were measured before the procedure and before the last treatment in 10 patients. Results The majority of patients (77%) were satisfied with the therapeutic outcomes. Approximately 66% of patients responded that the effects of this procedure persisted for longer than four months, and the majority of patients (77%) wanted to undergo this procedure again and would recommend this procedure to acquaintances. Regarding doctors’ evaluation, scores for improvement of skin surface roughness, elasticity, and brightness were significantly higher than those for improvement of moisture and fine wrinkle. Conclusions Intradermal injection of HA can have a rejuvenating effect on dry and tired facial skin, especially in improvement of skin surface roughness.

건강한 성인에서 인플루엔자 백신의 근육내 주사와 절반 용량 피부내 주사의 면역원성과 안전성 비교

조유미,기세윤,송준영,최원석,김정연,서유빈,정혜원,김우주,정희진,김성란,황인숙 대한감염학회 2006 감염과 화학요법 Vol.38 No.5

Background : Influenza is the representative respiratory infectious disease causing significant high morbidity. Vaccination is the most effective method to prevent influenza. To cope with both unstable supply and increasing demand of influenza vaccine with more flexibility, we studied the safety and immunogenicity of half dose intradermal injection of influenza vaccine in healthy adults compared with full dose intramuscular injection method. Materials and Methods : We conducted a randomized, open-label trial in healthy adults of age 15 to 64 years. Subjects were randomly assigned to receive either a recommended dose of influenza vaccine (Fluarix^(R), Injection Prefilled Syringe, GlaxoSmithKline, hemagglutinin antigen (HA) 15 ?g) via intramuscular route (designated as control group) or a half recommended dose (HA 7.5 ?g) via intradermal route (designated as experimental group). Blood samplings were done before and more than 28 days after vaccination. We measured the changes in hemagglutination-inhibition (HAI) antibody titers and compared geometric mean titers, seroconversion rates, seroconversion factors and seroprotection rates of each group. Local and systemic adverse events were assessed after vaccination. Results : In antibody titer against all three antigens (A/H1N1, A/H3N2, B) was more evident in intramuscular injection group but intradermal group with half dose showed acceptable immunogenicity fulfilling criteria for Committee for Proprietary Medicinal Products (CPMP). Likewise, seroprotection rates for all three viral strains showed no significant difference between the two groups. Although local reactions were significantly more frequent and lengthy in intradermal group than in intramuscular group, the reactions were mild and transient. Conclusion : Compared with intramuscular injection of full dose influenza vaccine, intradermal injection of half dose resulted in comparable immunogenicity in healthy adults. Intradermal administration of half dose influenza vaccine could be a practical alternative plan to expand the supplies of influenza vaccine, but further studies will be needed in high risk groups. 목적 : 인플루엔자는 매년 높은 이환율을 보이는 대표적인 호흡기 감염질환으로 백신 주사는 가장 효과적인 인플루엔자 예방법이다. 인플루엔자 백신 공급의 불안정, 백신 수요량의 증가에 보다 탄력적으로 대응하기 위하여 상용량보다 적은 용량의 백신(절반 용량)을 기존의 근육내 주사가 아닌 피부내 주사함으로써 충분한 방어항체가 형성되는지의 여부를 건강한 성인을 대상으로 알아보고자 하였다. 재료 및 방법 : 15-64세의 건강한 성인 자원자를 대상으로 무작위 개방표지시험(randomized, open-label trial)을 시행하였다. 이들을 실험군과 대조군으로 나누었고, 대조군에게는 인플루엔자 백신 제 용량(full-dose)을 근육 내 주사하였고 실험군에게는 인플루엔자 백신 절반 용량(l/2-dose)을 피부내 주사하였다. 주사 전과 주사 28일 이후에 혈구응집억제(HAI) 항체 검사를 시행하여 각 군의 기하평균 역가(geometric mean titer), 혈청전환율(seroconversion rate), 혈청전환인자(seroconversion factor), 혈청보호율(seroprotection rate)을 비교하였다. 또한 백신 주사 이후 국소적, 전신적 이상 반응 여부를 평가하였다. 결과: A/H1N1, A/H3N2, B의 세 항원에 대하여 근육내 주사 군에서 항체가의 상승이 보다 뚜렷하였으나 피부내 주사 군 역시 절반 용량 투여에도 불구하고 Committee for Proprietary Medicinal Products (CPMP) 기준을 만족하는 면역원성을 나타내었다. 또한 세 바이러스주 모두에 대한 혈청보호율은 두 주사 방법 간에 유의한 차이를 보이지 않았다. 백신 주사 후의 국소적 부작용은피부내 주사에서 더 빈번하고 오래 지속되었다. 그러나 이러한 부작용은 경미하였고 일시적이었다. 결론 : 인플푸엔자 백신을 권장량의 절반 용량으로 피부내 주사한 경우 제 용량을 근육내 주사한 경우와 유사한 면역원성을 나타내었다. 인플루엔자 백신의 피부내 주사는 백신 공급의 확대를 위한 현실적인 대안이 될 수 있을 것이나 고위험군에서의 추가 연구가 필요할 것이다.

대상포진 통증관리시 Lidocaine의 정맥내주입 및 피내주사에 병용된 경막외 스테로이드 주입은 이점이 있는다?

송선옥,윤종석,이덕희 대한마취과학회 2002 Korean Journal of Anesthesiology Vol.43 No.5

Background: An epidural blockade has been considered a standard therapy for the management of pain in acute herpes zoster. However, it has many complications. Recently, we experienced good analgesia with a combination therapy including intravenous lidocaine infusion and intradermal injection of a local anesthetic and steroid in acute herpes zoster. Therefore, this study was performed to evaluate the necessity of an epidural steroid injection, added in a combination therapy, on the pain control of acute herpes zoster. Methods: This retrospective study was based on the analysis of data of medical records. Forty-three patients suffering severe acute herpes zoster pain, were randomly divided into two groups. Intravenous indocaine infusion (5 mg/kg) and an intradermal injection of lidocaine and a steroid into the wound were used twice a week in the Lidocaine group ( n = 23), and in the Epidural group (n = 20), and epidural block with 0.5% lidocaine 6-8 ml with triamcinolone 30 mg was added once a week in addition to the above. We compared the efficacy of pain control using a pain relief scale (PRS) at 4 weeks after the initial visit to the pain clinic. Results: Both groups were similarly managed in pain control. There were no statistical differences comparing the PRS between the two groups. Conclusions: Our results suggest that an epidural steroid injection, added in a combination therapy such as an intravenous lidocaine infusion and an intradermal injection of a local anesthetic and steroid, has no more advantages for the management of pain in acute herpes zoster. A further prospective study is recommended to compare the efficacy of pain control and the incidence of postherpetic neuralgia in a large number of acute herpes zoster patients. (Korean J Anesthesiol 2002; 43: 594~599)