An open-label study to evaluate sildenafil for the treatment of lymphatic malformations.

BACKGROUND: Lymphatic malformations can be challenging to treat. Mainstay interventions including surgery and sclerotherapy are invasive and can result in local recurrence and complications. OBJECTIVE: We sought to assess the effect of 20 weeks of oral sildenafil on reducing lymphatic malformation volume and symptoms in children. METHODS: Seven children (4 boys, 3 girls; ages 13-85 months) with lymphatic malformations were given oral sildenafil for 20 weeks in this open-label study. The volume of the lymphatic malformation was calculated blindly using magnetic resonance imaging performed before and after 20 weeks of sildenafil. Lymphatic malformations were assessed clinically on weeks 4, 12, 20, and 32. Both the physician and parents evaluated the lymphatic malformation in comparison with baseline. RESULTS: Four subjects had a lymphatic malformation volume decrease (1.0%-31.7%). In 2 subjects, despite a lymphatic malformation volume increase (1.1%-3.7%), clinical improvement was noted while on sildenafil. One subject had a 29.6% increase in lymphatic malformation volume and no therapeutic response. Lymphatic malformations of all 6 subjects who experienced a therapeutic response on sildenafil softened and became easily compressible. Adverse events were minimal. LIMITATIONS: A randomized controlled trial will be necessary to verify the effects of sildenafil on lymphatic malformations. CONCLUSIONS: Sildenafil can reduce lymphatic malformation volume and symptoms in some children.

The effect of lidocaine when mixed with large gel particle hyaluronic acid filler tolerability and longevity: a six-month trial.

OBJECTIVES: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). MATERIALS AND METHODS: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. RESULTS: Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. CONCLUSION: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.