Editing Botulinum toxin (section)

===Cosmetic uses===
[[File:Dr Braun Performs a Botox Injection (4035273577).jpg|thumb|Botulinum toxin being injected in the human face]]
In cosmetic applications, botulinum toxin is considered relatively safe and effective<ref>{{cite journal |vauthors = Satriyasa BK |title = Botulinum toxin (Botox) A for reducing the appearance of facial wrinkles: a literature review of clinical use and pharmacological aspect |journal = Clinical, Cosmetic and Investigational Dermatology |volume = 12 |pages = 223–228 |date = 10 April 2019 |pmid = 31114283 |pmc = 6489637 |doi = 10.2147/CCID.S202919 |doi-access = free }}</ref> for reduction of facial [[wrinkles]], especially in the uppermost third of the face.<ref name=Small2014>{{cite journal |vauthors = Small R |title = Botulinum toxin injection for facial wrinkles |journal = American Family Physician |volume = 90 |issue = 3 |pages = 168–175 |date = August 2014 |pmid = 25077722 }}</ref> Commercial forms are marketed under the brand names Botox Cosmetic/Vistabel from [[Allergan]], Dysport/Azzalure from [[Galderma]] and [[Ipsen]], Xeomin/Bocouture from Merz, Jeuveau/Nuceiva from Evolus, manufactured by [[Daewoong Pharmaceutical|Daewoong]] in South Korea.<ref name="Krause_2019" /> The effects of botulinum toxin injections for [[glabella]]r lines ('11's lines' between the eyes) typically last two to four months and in some cases, product-dependent, with some patients experiencing a longer duration of effect of up to six months or longer.<ref name="Small2014" /> Injection of botulinum toxin into the muscles under facial wrinkles causes relaxation of those muscles, resulting in the smoothing of the overlying skin.<ref name=Small2014/> Smoothing of wrinkles is usually visible three to five days after injection, with maximum effect typically a week following injection.<ref name=Small2014/> Muscles can be treated repeatedly to maintain the smoothed appearance.<ref name=Small2014/>

DaxibotulinumtoxinA (Daxxify) was approved for medical use in the United States in September 2022.<ref name="Daxxify FDA label" /><ref name="Daxxify FDA snapshot" /> It is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (wrinkles between the eyebrows).<ref name="Daxxify FDA label" /><ref name="Daxxify FDA snapshot">{{cite web |title=Drug Trials Snapshot: Daxxify |website=U.S. [[Food and Drug Administration]] (FDA) |date=7 September 2022 |url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-daxxify |access-date=23 March 2024 |archive-date=1 February 2024 |archive-url=https://web.archive.org/web/20240201162717/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-daxxify |url-status=live }} {{PD-notice}}</ref><ref>{{cite press release |title=Revance Announces FDA Approval of Daxxify (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results |publisher=Revance |via=Business Wire |date=8 September 2022 |url=https://www.businesswire.com/news/home/20220908005320/en/Revance-Announces-FDA-Approval-of-DAXXIFY%E2%84%A2-DaxibotulinumtoxinA-lanm-for-Injection-the-First-and-Only-Peptide-Formulated-Neuromodulator-With-Long-Lasting-Results |access-date=24 September 2022 |archive-date=10 September 2022 |archive-url=https://web.archive.org/web/20220910163940/https://www.businesswire.com/news/home/20220908005320/en/Revance-Announces-FDA-Approval-of-DAXXIFY%E2%84%A2-DaxibotulinumtoxinA-lanm-for-Injection-the-First-and-Only-Peptide-Formulated-Neuromodulator-With-Long-Lasting-Results/ |url-status=live }}</ref> DaxibotulinumtoxinA is an acetylcholine release inhibitor and neuromuscular blocking agent.<ref name="Daxxify FDA label" /> The FDA approved daxibotulinumtoxinA based on evidence from two clinical trials (Studies GL-1 and GL-2), of 609 adults with moderate to severe glabellar lines.<ref name="Daxxify FDA snapshot" /> The trials were conducted at 30 sites in the United States and Canada.<ref name="Daxxify FDA snapshot" /> Both trials enrolled participants 18 to 75 years old with moderate to severe glabellar lines.<ref name="Daxxify FDA snapshot" /> Participants received a single intramuscular injection of daxibotulinumtoxinA or placebo at five sites within the muscles between the eyebrows.<ref name="Daxxify FDA snapshot" /> The most common side effects of daxibotulinumtoxinA are headache, drooping eyelids, and weakness of facial muscles.<ref name="Daxxify FDA snapshot" />

LetibotulinumtoxinA (Letybo) was approved for medical use in the United States in February 2024.<ref name="Letybo FDA label" /><ref name="Letybo FDA snapshot">{{cite web |title=Drug Trials Snapshots: Letybo |website=U.S. [[Food and Drug Administration]] (FDA) |date=29 February 2024 |url=https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-letybo |access-date=23 March 2024 |archive-date=23 March 2024 |archive-url=https://web.archive.org/web/20240323195046/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-letybo |url-status=live }} {{PD-notice}}</ref><ref>{{cite report |title=New Drug Therapy Approvals 2024 |website=U.S. [[Food and Drug Administration]] (FDA) |date=January 2025 |url=https://www.fda.gov/media/184967/download |format=PDF |access-date=21 January 2025 |archive-url=https://web.archive.org/web/20250121045744/https://www.fda.gov/media/184967/download |archive-date=21 January 2025 |url-status=live }}</ref> It is indicated to temporarily improve the appearance of moderate-to-severe glabellar lines.<ref name="Letybo FDA label" /><ref>{{cite web |title=Novel Drug Approvals for 2024 |website=U.S. [[Food and Drug Administration]] (FDA) |date=29 April 2024 |url=https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 |access-date=30 April 2024 |archive-date=30 April 2024 |archive-url=https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 |url-status=live }}</ref> The FDA approved letibotulinumtoxinA based on evidence from three clinical trials (BLESS I [NCT02677298], BLESS II [NCT02677805], and BLESS III [NCT03985982]) of 1,271 participants with moderate to severe wrinkles between the eyebrows for efficacy and safety assessment.<ref name="Letybo FDA snapshot" /> These trials were conducted at 31 sites in the United States and the European Union.<ref name="Letybo FDA snapshot" /> All three trials enrolled participants 18 to 75 years old with moderate to severe glabellar lines (wrinkles between the eyebrows).<ref name="Letybo FDA snapshot" /> Participants received a single intramuscular injection of letibotulinumtoxinA or placebo at five sites within the muscles between the eyebrows.<ref name="Letybo FDA snapshot" /> The most common side effects of letibotulinumtoxinA are headache, drooping of eyelid and brow, and twitching of eyelid.<ref name="Letybo FDA snapshot" />