Safety, efficacy, and onset of a novel botulinum toxin type A (Nabota) for the treatment of glabellar frown lines: a single-arm, prospective, phase 4 clinical study

BACKGROUND: Safety, efficacy, and time to onset of effect of botulinum toxin type A is of importance to persons who seek improvement in glabellar frown lines, but this has not been well studied. The aim of this study was to determine the safety, efficacy, and onset of action of a newly developed botulinum toxin type A (Nabota) for the treatment of glabellar frown lines. METHODS: This was a single-arm, open-label, and phase 4 clinical study. Forty-two subjects with glabellar lines were treated with five times of intramuscular injection of 0.1 mL (4 U/0.1 mL) for a total of 20 U of Nabota. Efficacy and safety were assessed at 2, 3, 4, 5, and 14 days. Efficacy was assessed by the investigator and it was defined as a 1-point change on a 4-point scale. RESULTS: Improvement in glabellar frown lines at maximum frown was observed in 85.4% of subjects 2 days after administration. Improvement in glabellar lines at rest was observed in 51.2% of subjects 2 days after administration, and the proportion of subjects showing improvement increased with time. No severe adverse events were recorded. CONCLUSION: Onset of action was observed in the majority of subjects by 2 days after administration of Nabota. In addition, Nabota was found to be safe and effective for the treatment of glabellar frown lines.

The Use of Locally Applied Vibration to Minimize Pain during Fractional CO₂ Laser Therapy in Living Liver-Donor Scar Management

BACKGROUND: Fractional CO₂ laser is an effective treatment for scars, but most patients complain about sharp burning pain, even after the application of lidocaine ointment. This study analyzed the impact of a vibrating device to nonpharmacologically reduce the acute pain of laser treatment, in accordance with the gate control theory of pain management. METHODS: This is a prospective study performed from May 2013 through March 2014. Fifty-three patients (mean age, 26.7 years; range, 16–44 years) who had donated livers for liver transplantation were treated with a fractional CO2 laser (10,600 nm; model eCO₂, Lutronic Corp) for their abdomen scars. Laser treatment was applied 4 months after surgery. A commercially available, locally applied vibrating device (model UM-30M, Unix Electronics Co. Ltd.) was used, in an on-and-off pattern, together with the CO2 laser. A visual analogue scale (VAS; 0, no pain; 10, most severe pain) of pain sensation was assessed and statistically analyzed using a paired t-test. RESULTS: The average VAS score for pain with the vibrating device was 4.60 and the average VAS score without the vibrating device was 6.11. The average difference between scores was 1.51 (P=0.001). CONCLUSIONS: A locally applied vibrating device was demonstrated to be effective in reducing pain when treating with a fractional CO₂ laser. Vibration treatment could be helpful when treating scars with fractional CO₂ laser in pain-sensitive patients, particularly children.