BACKGROUND: The use of intradermal botulinum toxin A (onabotulinumtoxinA) remains a relatively new technique and is an off-label cosmetic application for facial skin rejuvenation. There is little documented clinical evidence of the objective benefits of this therapy. PURPOSE: To determine whether intradermal facial onabotulinumtoxinA injection has any benefits. STUDY DESIGN: Interventional, comparative, split face clinical trial. METHODS: Informed consent was obtained from 10 physicians. One half of the physician's faces were randomly injected with onabotulinumtoxinA (2 U/0.1 mL; 30 facial injections on half of the face, each 0.1 mL) intradermally and the other half of the face with normal saline (30 facial injections on half of the face, each 0.1 mL). The injecting clinician and the subjects were blinded to the contents of the syringes. One and 4 weeks later, two neutral, blinded observers assessed the subjects in person. The patients were also photographed in ambient light surroundings and the same observers compared the halves of their faces in photographs and rated them on a scale of -4 to +4. RESULTS: Global improvement in skin texture and tightness was noted in the post-treatment photographs (the skin appeared to be tenser and smoother), although there was no difference between the two groups and, hence, the changes could not be clinically ascribed to the intradermal botulinum toxin injections. No other meaningful clinical difference could be demonstrated between the two sides of the face, in any of the 10 subjects, in person or in photographs. The small study sample precluded formal statistical analysis. CONCLUSION:Intradermal botulinum toxin A injection does not appear to have any benefit in facial rejuvenation.
RCT Entities:
BACKGROUND: The use of intradermal botulinum toxin A (onabotulinumtoxinA) remains a relatively new technique and is an off-label cosmetic application for facial skin rejuvenation. There is little documented clinical evidence of the objective benefits of this therapy. PURPOSE: To determine whether intradermal facial onabotulinumtoxinA injection has any benefits. STUDY DESIGN: Interventional, comparative, split face clinical trial. METHODS: Informed consent was obtained from 10 physicians. One half of the physician's faces were randomly injected with onabotulinumtoxinA (2 U/0.1 mL; 30 facial injections on half of the face, each 0.1 mL) intradermally and the other half of the face with normal saline (30 facial injections on half of the face, each 0.1 mL). The injecting clinician and the subjects were blinded to the contents of the syringes. One and 4 weeks later, two neutral, blinded observers assessed the subjects in person. The patients were also photographed in ambient light surroundings and the same observers compared the halves of their faces in photographs and rated them on a scale of -4 to +4. RESULTS: Global improvement in skin texture and tightness was noted in the post-treatment photographs (the skin appeared to be tenser and smoother), although there was no difference between the two groups and, hence, the changes could not be clinically ascribed to the intradermal botulinum toxin injections. No other meaningful clinical difference could be demonstrated between the two sides of the face, in any of the 10 subjects, in person or in photographs. The small study sample precluded formal statistical analysis. CONCLUSION: Intradermal botulinum toxin A injection does not appear to have any benefit in facial rejuvenation.
Authors: Hema Sundaram; Po-Han Huang; Nai-Jen Hsu; Chang Hun Huh; Woffles T L Wu; Yan Wu; Daniel Cassuto; Martina J Kerscher; Kyle Koo-Il Seo Journal: Plast Reconstr Surg Glob Open Date: 2016-12-07
Authors: Ying-Ying Miao; Juan Liu; Jie Zhu; Yan-Ling Tao; Jia-An Zhang; Dan Luo; Bing-Rong Zhou Journal: Biomed Res Int Date: 2017-02-07 Impact factor: 3.411