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Canada Global HARMONY Study

Background: Canada Global HARMONY evaluated psychological/emotional impact of multimodal aesthetic treatment with deoxycholic acid (ATX-101), hyaluronic acid (HA) fillers (VYC-12L, VYC-15L, VYC-17.5L, VYC-20L), onabotulinumtoxinA, and medical-grade skincare (cleanser, serum, moisturizer, sunscreen). Methods: This 12-month, prospective, open-label, multisite study enrolled adults (30–65 years) with mild-to-moderate facial photodamage and moderate-to-severe upper facial rhytides. Participants received ≥1 HA fillers (2 optional touch-ups) and onabotulinumtoxinA (1 optional touch-up); a subset with moderate-to-severe submental fullness received 1-6 ATX-101 treatments prior to fillers/toxin. Skincare products were applied daily starting from filler treatment. The primary efficacy endpoint was change from baseline (CFB) to final visit in FACE-Q Satisfaction with Facial Appearance Overall score. Secondary endpoints included CFB in FACE-Q Expectations of Life Change, Aging Appraisal, Psychological Function, Social Function, and Satisfaction with Skin scores; Self-Perception of Age (SPA); and improvement on Global Aesthetic Improvement Scale (GAIS). Safety was monitored throughout. Results: Of 59 enrolled, 58 participants (median age, 54 years; 87.9% female) were treated; 13 participants qualified to receive ATX-101. Overall Satisfaction with Facial Appearance scores significantly improved (30.3 points; P<0.0001). Similar results were observed for Aging Appraisal, Psychological Function, and Social Function scores (P<0.0001 for all endpoints). On the SPA measure, 43 participants (74%) reported they looked an average of 3.5 years younger at the final visit. Most (>98%) participants/investigators rated improved/much improved on GAIS. Twenty-nine participants (50%) reported 68 treatment-emergent adverse events; none were serious and all resolved spontaneously. Conclusions: This study shows significant improvements in patient-reported satisfaction with multimodal facial aesthetic treatment.

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