Treatment of Upper Facial Lines With DaxibotulinumtoxinA for Injection: Results From an Open-Label Phase 2 Study.

BACKGROUND: Simultaneous treatment of moderate-to-severe upper facial lines is reflective of real-world clinical practice. OBJECTIVE: To evaluate the efficacy and safety of daxibotulinumtoxinA-lanm for injection (DAXI) for simultaneous treatment of glabellar, forehead, and lateral canthal (LC) lines. METHODS: In this open-label, single-arm Phase 2 study, patients (48 enrolled, 94% completed, follow-up 24-36 weeks) received DAXI 40U (glabellar), 32U (forehead), and 48U (LC) lines. Key efficacy endpoints: percentages of patients achieving none/mild wrinkle severity (investigator-rated) for each upper facial line scale at Week 4. RESULTS: At Week 4, most patients achieved none/mild wrinkle severity (investigator-rated): glabellar (96%), forehead (96%), and LC (92%). Median times to loss of none/mild response (investigator- and patient-rated) among all patients were: 24.6 (glabellar), 20.9 (forehead), and 24.9 (LC) weeks; and 25.0, 24.0, and 28.1 weeks, respectively, among Week-4 responders. At Week 4, most patients reported improvements (Global Aesthetic Improvement Scale: 96%-98%) and high satisfaction rates (85%-98%). Five patients experienced treatment-related adverse events: injection-site erythema (3 patients/7 events), facial discomfort (2 patients/2 events), and headache (1 patient/1 event). No patients experienced eyebrow or eyelid ptosis. CONCLUSION: Simultaneous treatment of upper facial lines with DAXI was well tolerated and demonstrated high response rates, extended duration, and high patient satisfaction. CLINICAL TRIAL REGISTRY: https://clinicaltrials.gov/ct2/show/NCT04259086.

89% Vichy mineralizing water with hyaluronic acid is a well-tolerated adjunct treatment that helps restore skin barrier function in dry skin-related inflammatory dermatoses and post-procedure skin care: A Canadian study.

INTRODUCTION: Minéral 89 (M89), comprised of 89% Vichy mineralizing water and hyaluronic acid, has been formulated to help strengthen and restore skin barrier. AIM: Assess tolerance and efficacy of M89 in post-esthetic procedures and dry skin-related facial dermatoses. METHOD: Adults post-esthetic procedure or presenting with inflammatory dermatoses (47 subjects; mean age 40.9 ± 13.2 years; any Fitzpatrick or skin phototype), applied M89 for 4 weeks, once or twice daily, as an adjuvant treatment. Information on clinical signs and subject-reported symptoms, skin characteristics, tolerance, and subject and investigator satisfaction were collected. RESULTS: Following 4 weeks of M89 use, significant decreases with complete resolution of erythema (27.6%), desquamation (29.8%), irritation (32%), and skin dehydration (35.8%), as compared to baseline signs and symptoms, were observed. Overall grading improvements for erythema (84.8%; p < 0.001), desquamation (91.7%; %; p < 0.003), irritation (91.7%; %; p < 0.015), and skin hydration (46.2%; p < 0.015) were noted. There was no significant improvement in papules and pustules. Evaluation of subjective signs demonstrated significant decreases in skin sensations such as burning (-73%; p < 0.0001), itching (-71%; p < 0.0001), stinging-tingling (-66.7%; p < 0.0001), as well as in skin dryness (-60%; p < 0.0001). M89 texture was rated very pleasant by 90% of patients. Investigators assessed M89 tolerance to be either good or very good (93%), and satisfactory or highly satisfactory impact on patient's skin (91.5%). CONCLUSION: M89 is a highly tolerable adjuvant treatment that significantly improved clinical signs and symptoms related to a compromised skin barrier in various facial dermatoses and post-aesthetic procedures.

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2).

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. METHODS: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). RESULTS: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). CONCLUSIONS: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.