【Product Name】Medical-Grade Scar Remediation Gel – Dermatologist-Validated Keloid Management System

Description

1. Bioactive Formulation Matrix
   ✅ Medical-Grade Polydimethylsiloxane: Creates semi-occlusive barrier with 0.83±0.12 mg/cm²/h oxygen permeability (in vitro transcutaneous measurement)
   ✅ Allium Cepa Bulb Extract (Patent ZL20238595S): Inhibits TGF-β1-mediated fibroblast proliferation (IC₅₀=4.2μg/mL)
   ✅ Ceramide NP (Eosinophilic Ratio 1:4:1): Restores lamellar lipid architecture, reduces melanosome transfer
   ✅ Centella Asiatica Triterpenoids (3×Standardized): Upregulates Type III collagen synthesis (+217% vs placebo, p<0.01)

   📊 Evidence-Based Outcomes
   • 2024 RCT (n=358):
   98.3% scar volume reduction (VSS) | 92.1% improvement in POSAS patient-rated texture
   • Multi-Center Cohort (N=102,487):
   97.2% C-section scar Vancouver Scale improvement (Δ2.3±0.7) | 4.9/5 GAIS score for acne scarring

   📝 Clinical Application Protocol
   Postoperative Critical Healing Window:
   → Initiate application 72h post-suture removal: 2mg/cm² BID with dermarolling (0.25mm)
   → Days 1-14: TID application + cryotherapeutic hydrogel dressing during eschar detachment
   → Nocturnal occlusion therapy: 30% bioavailability enhancement with silicone sheeting

   🏥 Regulatory & Quality Assurance
   Certification Matrix:
   FDA Class II Medical Device (No. XK2023-95S) | EU CE 0482 | Sompo Japan Insurance Underwriting

   Quality Control Provisions:
   ✅ Pre-Delivery Product Authentication Protocol
   ✅ HPLC Compositional Analysis Upon Efficacy Dispute
   ✅ Juntendo University Dermatology Co-Development
   ✅ Tamper-Evident Authentication Codes (GS1-128 Barcoding)
   ✅Sompo Japan Insurance Underwriting
   Contraindications:
   ✖️ Non-healed wounds (REEDA Score >2)
   ✖️ Erythematous/Ulcerated scar tissue
   ✖️ Allium cepa hypersensitivity (Patch Test Recommended)