Weekly Cosmetic Research Analysis
This week saw clinically actionable advances across aesthetic therapeutics and safety: a multicenter phase III trial showed an animal‑component–free botulinum toxin (CKDB‑501A) is non‑inferior to onabotulinumtoxinA with sustained effect to 16 weeks and no neutralizing antibodies; a translational nonhuman primate model supports super‑selective intra‑arterial hyaluronidase thrombolysis up to 24 hours after hyaluronic acid embolism; and a randomized trial found a cyclized hexapeptide‑9 outperformed
Summary
This week saw clinically actionable advances across aesthetic therapeutics and safety: a multicenter phase III trial showed an animal‑component–free botulinum toxin (CKDB‑501A) is non‑inferior to onabotulinumtoxinA with sustained effect to 16 weeks and no neutralizing antibodies; a translational nonhuman primate model supports super‑selective intra‑arterial hyaluronidase thrombolysis up to 24 hours after hyaluronic acid embolism; and a randomized trial found a cyclized hexapeptide‑9 outperformed retinol on multiple wrinkle metrics. Complementary work highlights greener manufacturing/assays and environmental impacts of cosmetic ingredients, signaling shifts toward safer-by‑design products and better acute management of injectable complications.
Selected Articles
1. Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial.
In a multicenter, randomized, double‑blind phase III trial (n=300), CKDB‑501A — a botulinum toxin formulation free of animal‑derived components including human serum albumin — demonstrated non‑inferiority to onabotulinumtoxinA for moderate‑to‑severe glabellar lines. At week 4, 80.69% in the CKDB group achieved ≥2‑point improvement on the Facial Wrinkle Scale versus 70.83% for the comparator; efficacy was sustained to 16 weeks and no neutralizing antibodies or hypersensitivity events were observed.
Impact: Provides high‑level randomized evidence supporting an animal‑component‑free neuromodulator as a safe, effective alternative — addressing biocompatibility and immunogenicity concerns for widespread aesthetic use.
Clinical Implications: Clinicians can consider CKDB‑501A as an alternative to onabotulinumtoxinA for moderate‑to‑severe glabellar lines, with comparable 4–16 week efficacy and a favorable immunogenicity profile; monitor durability over repeated cycles in practice.
Key Findings
- Week‑4 ≥2‑point FWS improvement: CKDB‑501A 80.69% vs onabotulinumtoxinA 70.83% (non‑inferior; 95% CI 0.09–19.55; p=0.0491).
- Sustained efficacy through 16 weeks with ~70% maintaining ≥1‑point improvement.
- Comparable safety profiles; no local/distant spread events, no hypersensitivity, and no neutralizing antibodies detected.
2. Nonhuman Primate Model of Super-selective Intra-arterial Ophthalmic Arterial Interventional Thrombolysis for Treatment of Ophthalmic Arterial Embolism Resulting From Hyaluronic Acid Filler Cosmetic Injection.
A rhesus monkey model of ophthalmic artery embolism induced by intra‑arterial hyaluronic acid was developed and reperfused via super‑selective intra‑arterial hyaluronidase thrombolysis. Recanalization performed at 1, 4, and even 24 hours improved visual function, though residual electroretinographic dysfunction and histologic retinal injury persisted with longer ischemic intervals; scRNA‑seq showed rhodopsin downregulation with prolonged ischemia.
Impact: Fills a critical translational evidence gap for managing filler‑induced ophthalmic arterial embolism and supports an extended (up to 24 h) interventional treatment window for intra‑arterial hyaluronidase.
Clinical Implications: Supports consideration of super‑selective intra‑arterial hyaluronidase thrombolysis within up to 24 hours after HA embolism in facial filler complications, with counseling about possible residual deficits and need for rapid referral pathways.
Key Findings
- Established rhesus monkey OA embolism model via intra‑arterial HA injection and achieved reperfusion with intra‑arterial hyaluronidase.
- Recanalization at 1, 4, and 24 hours improved visual function but ERG and histology showed residual damage correlated with ischemia duration.
- scRNA‑seq demonstrated decreased rhodopsin expression with longer ischemic times, suggesting molecular correlates of damage.
3. Novel Cyclized Hexapeptide-9 Outperforms Retinol Against Skin Aging: A Randomized, Double-Blinded, Active- and Vehicle-Controlled Clinical Trial.
In a randomized, double‑blind, active‑ and vehicle‑controlled trial over 56 days, low‑concentration cyclized hexapeptide‑9 (0.002%) significantly reduced the number, area, and roughness of crow's feet and forehead wrinkles, outperforming 0.002% retinol on most outcomes. Effects appeared to augment with time across the study period, suggesting the cyclized peptide is a potent topical anti‑aging candidate with potentially favorable tolerability.
Impact: Provides head‑to‑head randomized evidence that a next‑generation cyclized peptide can outperform retinol on objective wrinkle metrics, potentially reshaping topical anti‑aging first‑line choices.
Clinical Implications: CHP‑9 may be considered for patients intolerant of retinoids or seeking alternatives with comparable or superior wrinkle improvements; longer‑term safety and larger, diverse cohorts should be evaluated before broad adoption.
Key Findings
- CHP‑9 significantly reduced number, area, and roughness of crow's feet and forehead wrinkles; retinol showed improvement on fewer parameters.
- Most outcomes favored CHP‑9 over retinol except crow's feet roughness where differences were not significant.
- Time‑dependent augmentation of CHP‑9 efficacy observed over 56 days.