PMID- 19289677 OWN - NLM STAT- MEDLINE DCOM- 20090605 LR - 20120924 IS - 1538-3660 (Electronic) IS - 1521-2491 (Linking) VI - 11 IP - 2 DP - 2009 Mar-Apr TI - Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines. PG - 77-83 LID - 10.1001/archfacial.2009.5 [doi] AB - OBJECTIVE: To evaluate the long-term safety of repeated administrations of a new botulinum toxin type A (Reloxin; Medicis Pharmaceutical Corp, Scottsdale, Arizona) in the treatment of moderate to severe glabellar lines. METHODS: Open-label assessment of 1200 patients receiving as many as 5 treatments of Reloxin over a 13-month period. The product was diluted in 2.5-mL sterile physiologic saline solution, 0.9%, without preservative to a concentration of 50 U of Reloxin per 0.25 mL of solution. Investigators injected 0.05 mL of the solution (10 U each) into each of 5 injection sites in the glabellar area on day 0 of each treatment cycle. There was a minimum 85-day gap between treatments. Postinjection clinical evaluation was performed on days 14 and 30 and monthly thereafter until retreatment, study completion, or early termination. The patients were telephoned on day 7 to check for adverse events (AEs) and concomitant medications, and patient diaries were used to document the onset of treatment effect. RESULTS: The majority (72%) of treatment-emergent AEs were considered unlikely or not related to study treatment. Probably or possibly related treatment-emergent AEs occurred in 36% of patients. The most frequently occurring related AEs were injection site disorders (18%), nervous system disorders (14% and 12% headache), and eye disorders (9%). Related AEs around the injection site or eyes were usually reported by day 7 and then resolved. Reported ptosis does not differentiate between brow ptosis and eyelid ptosis. A total of 45 patients had a total of 55 instances of ptosis across all cycles, with most episodes lasting less than 3 weeks. The rates of ptosis decreased during successive cycles from 2.4% in cycle 1 to 0.6% in cycle 5. The proportion of patients reporting an onset of response by day 7 ranged from 93% to 95%. By investigator assessment, the response rate (patients reporting none or mild glabellar line severity scale scores on day 30) ranged from 80% to 91% during cycles 1 to 5. CONCLUSIONS: There was no evidence of cumulative AEs or tachyphylaxis with multiple Reloxin treatments over a period of 13 months. The treatments were well tolerated. The rates of ptosis decreased over successive cycles, and the proportion of responders by day 7 ranged from 93% to 95%. FAU - Moy, Ronald AU - Moy R AD - Moy-Fincher Medical Group, 100 UCLA Medical Plaza, Ste 590, Los Angeles, CA 90024, USA. rmoy@ucla.edu FAU - Maas, Corey AU - Maas C FAU - Monheit, Gary AU - Monheit G FAU - Huber, M Barbara AU - Huber MB CN - Reloxin Investigational Group LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Arch Facial Plast Surg JT - Archives of facial plastic surgery JID - 100883500 RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Botulinum Toxins, Type A/adverse effects/*therapeutic use MH - *Face MH - Female MH - Humans MH - Injections MH - Male MH - Middle Aged MH - Neuromuscular Agents/adverse effects/*therapeutic use MH - Skin Aging/*drug effects MH - Treatment Outcome MH - United States EDAT- 2009/03/18 09:00 MHDA- 2009/06/06 09:00 CRDT- 2009/03/18 09:00 PHST- 2009/03/18 09:00 [entrez] PHST- 2009/03/18 09:00 [pubmed] PHST- 2009/06/06 09:00 [medline] AID - 11/2/77 [pii] AID - 10.1001/archfacial.2009.5 [doi] PST - ppublish SO - Arch Facial Plast Surg. 2009 Mar-Apr;11(2):77-83. doi: 10.1001/archfacial.2009.5.