A prospective, open-label, multicentric, single-arm, post-marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation.

BACKGROUND: Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation. AIM: The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24 mg with Lidocaine 3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation. METHOD: Patients between the age groups of 18 and 75 years, who were seeking soft tissue augmentation treatment on the face and with wrinkle severity score (WSS) ≥2 for bilateral Nasolabial Folds (NLF), were included in the study. The appropriate quantity of the filler was injected at the treatment site. Clinical efficacy assessments were conducted independently at 3 and 6 months after baseline. Clinical efficacy was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic Improvement Scale (GAIS). RESULTS: The mean pain score was found to be 2.57 ± 2.06 immediately after injection which was reduced to 0.1 ± 0.675 at 15 min and this further subsided to "No Pain" in any of the participants at 60 min post the injection. WSRS mean score before treatment was 2.76, which were significantly reduced to 2.14, at 3 months. Majority of participants found an improvement in the marionette line severity. Also, significant improvements were seen in the perioral and lip areas. The Study filler was well-tolerated and no side effects were reported. CONCLUSION: The study indicates that this particular filler, HA+L, is useful for cosmetic improvements in the nasolabial folds and for enhancement of the lips.

Efficacy and safety of itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: results of a double-blind, randomized, placebo-controlled, phase-III study.

BACKGROUND: Itolizumab, a humanized monoclonal antibody to CD6, is a novel therapeutic agent evaluated in chronic plaque psoriasis. OBJECTIVE: We sought to assess the safety and efficacy of itolizumab in moderate to severe chronic plaque psoriasis. METHODS: A total of 225 patients were randomized (2:2:1) to 2 different itolizumab arms (A or B; A = 4-week loading dose of 0.4 mg/kg/wk followed by 1.6 mg/kg every 2 weeks; B = 1.6/mg every 2 weeks) or placebo. At week 12, the placebo arm was switched to 1.6 mg/kg itolizumab every 2 weeks. The primary end point was the proportion of patients with at least 75% improvement in Psoriasis Area and Severity Index score at week 12. RESULTS: At week 12, 27.0% in arm A (P = .0172 vs placebo), 36.4% in B (P = .0043 vs placebo), and 2.3% in the placebo arm had at least 75% improvement in Psoriasis Area and Severity Index score. At week 28, the proportion with at least 75% improvement in Psoriasis Area and Severity Index score was comparable: 46.1%, 45.5%, and 41.9% for A, B, and placebo, respectively. In weeks 1 to 12, the incidence of all adverse events was comparable across arms (A, 43%; B, 38%; placebo, 47%) and the incidence of infections was not greater than placebo (11.1%, 8.9%, and 18.6% for A, B, and placebo). LIMITATIONS: No active comparator is a limitation. CONCLUSIONS: Itolizumab is an effective and well-tolerated novel biological therapy in moderate to severe psoriasis.