A Multi-Center, Open-Label, Prospective Study of Cannula Injection of Small-Particle Hyaluronic Acid Plus Lidocaine (SPHAL) for Lip Augmentation.

BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).

METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).

RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).

CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.

J Drugs Dermatol. 2018;17(1):10-16.

Nepafenac dosing frequency for ocular pain and inflammation associated with cataract surgery.

PURPOSE: Nepafenac ophthalmic suspension 0.1% was dosed topically once (QD), twice (BID), or three-times (TID) daily to assess the resolution of ocular pain and anterior-segment inflammation following cataract surgery. METHODS: This was a prospective, multicenter, double-masked, randomized, placebo-controlled study of 212 adults. Patients received nepafenac 0.1% or placebo, 1 drop QD, BID, or TID beginning 1 day before cataract surgery, continuing on the day of surgery, and for 14 days thereafter. One (1) additional drop was administered 30-120 min prior to surgery. The primary efficacy endpoint was percent of treatment failures (>or=16 aqueous cells, aqueous flare = severe, or ocular pain score = moderately severe or severe) through postoperative day 14. RESULTS: On days 7 and 14, the QD, BID, and TID all nepafenac posologies significantly reduced the percent of treatment failures, compared to placebo ( p

Bupropion and paroxetine differentially influence cardiovascular and neuroendocrine responses to stress in depressed patients.

BACKGROUND: There exists a need to identify safe and effective treatments for depression in patients with coronary heart disease (CHD). METHODS: Using a cross-sectional design, 17 depressed patients being treated with bupropion (200-450 mg/day) were compared with 17 depressed patients being treated with paroxetine (10-50 mg/day) and with a group of 15 unmedicated, non-depressed controls for cardiovascular, neuroendocrine and heart rate variability (HRV) measures at rest and in response to mental and physical stressors. RESULTS: Regardless of treatment, both treated groups exhibited blunted plasma cortisol, plasma epinephrine, systolic blood pressure, cardiac output, and pre-ejection period responses to mental stressors relative to controls. Bupropion treated individuals exhibited greater total peripheral resistance (TPR) increases than either the paroxetine or control groups, and greater plasma norepinephrine (NE) increases to mental stressors than the paroxetine group. The bupropion group also displayed reduced HRV at rest relative to the controls and during orthostatic challenge relative to both the control and paroxetine groups. LIMITATIONS: Despite the fact that the treated groups were well matched for depression and other psychiatric histories, lack of randomization into treatment arms may be associated with a selection bias in the two treated groups. CONCLUSIONS: Although both pharmacological treatments were associated with a blunting of some cardiovascular and neuroendocrine responses to stress relative to controls, which may be reflective of their therapeutic mechanisms of action, the results of our study also suggest that bupropion is associated with a more detrimental autonomic profile than paroxetine, as reflected in increased TPR and NE, and reduced HRV. The results of this study may have implications for the pharmacological treatment of depression in CHD patients.

Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye.

PURPOSE: To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms. METHODS: Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study. RESULTS: The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were "refreshed longer" compared to those in the Control group (p = 0.033 and p = 0.037, respectively). CONCLUSIONS: The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.