Authors: Muhammad Tayyab Azam, MBBS , Muhammad Hussain Azam, MBBS , Muhammad Hassan Azam, MBBS , Shahzad Ashraf, MBBS , Muhammad Arif Khan, MBBS , Hasibullah Aminpoor, MD
Abstract: Upper facial lines (UFLs), including glabellar frown lines (GFLs), horizontal forehead lines (HFLs), and lateral canthal lines (LCLs) are prevalent aesthetic concerns addressed with botulinum neurotoxin type A (BoNT-A). IncobotulinumtoxinA, a highly purified BoNT-A formulation, is utilized for simultaneous UFLs treatment; yet, comprehensive synthesized evidence is limited. This study aimed to systematically evaluate the efficacy and safety of IncobotulinumtoxinA compared with placebo for the simultaneous treatment of UFLs in adults, following PRISMA 2020 guidelines. Comprehensive searches of PubMed, Embase, Cochrane CENTRAL, ICTRP, and ClinicalTrials.gov were performed to identify randomized controlled trials (RCTs) evaluating IncobotulinumtoxinA for combined UFLs treatment. The primary outcome was ≥1-grade improvement on Day 30. Secondary outcomes included ≥2-grade improvement and Global Aesthetic Improvement Scale (GAIS) scores. Safety outcomes included adverse events (AEs), treatment-emergent adverse events (TEAEs), and headaches. Three RCTs (n = 704) were included. Pooled analysis using random-effects model demonstrated a significant ≥1-grade improvement at Day 30 in IncobotulinumtoxinA compared with placebo across all regions: GFLs (RR 21.49, 95% CI: 9.89-46.73), HFLs (RR 19.17, 95% CI: 9.23-39.80), and LCLs (RR 11.68, 95% CI: 7.49-18.20), all P < .00001. A ≥ 2-grade improvement similarly favored treatment across all areas (RRs 76.26-115.04; all P < .00001). Investigator-assessed GAIS scores also improved significantly (MD 2.29, 95% CI: 2.11-2.46, P < .00001). Serious AEs were lower with IncobotulinumtoxinA (RR 0.14, P = .03). There was no significant difference in TEAEs and headaches from placebo. IncobotulinumtoxinA demonstrates statistically significant efficacy and a comparable safety profile vs placebo for simultaneous UFLs treatment. These findings support its use in aesthetic practice, warranting further long-term investigation.
