DeneB Classic H

Clinical Monograph: DeneB Classic-H (Hyaluronic Acid 20 mg/mL)

1. Classification and Chemical Overview

• Active Composition: Cross-linked sodium hyaluronate at a concentration of 20 mg/mL, combined with 0.3% (3 mg/mL) lidocaine for local anesthetic comfort during deep administration.

  kstation

• Proprietary Technology: Manufactured using multi-stage cross-linking (such as MDM / Micro-bead Monophasic technology), which optimizes structural density, reduces residual cross-linking agents (BDDE), and creates a firm, cohesive gel matrix.

  kstation

• Therapeutic Class: High-viscosity subcutaneous body filler / Soft-tissue augmentation device.

  DermaHub

• Regulatory Status: Professional-use medical device requiring administration exclusively by trained medical or aesthetic practitioners.

2. Mechanism of Action and Pharmacodynamics

• Structural Volumization: Due to its high viscoelasticity and firm gel structure (high extrusion force profile), DeneB Classic-H provides robust structural support and lifting capacity.

  DermaHub

• Gel Stability & Low Migration: The micro-bead monophasic matrix resists rapid enzymatic degradation and compression, ensuring that the product maintains its projected shape and stays localized within the target tissue plane without migrating.

  kstation

• Hydration & Biostimulation: Beyond immediate volumetric shaping, the hydrophilic hyaluronic acid matrix binds water molecules to improve localized tissue hydration and support skin barrier quality.

3. Approved Clinical Indications and Dosing Scope

• Indications:

  • Non-surgical body contouring and major volume restoration.

    kstation

  • Enhancement and shaping of the buttocks, hips, calves, and thighs.

    Envision Medical LLC

  • Correction of deep structural body asymmetries or hollowed contours.

    Body Filler Korea

• Administration & Depth:

  • Supplied in a 10 mL pre-filled sterile syringe for efficient coverage of broad anatomical zones.

    Body Filler Korea

  • Injected strictly into the deep dermal to subcutaneous fatty layer using appropriate sterile tunneling or depot techniques.

    Body Filler Korea

• Duration of Effect: Typically persists between 12 to 18 months, depending on the patient’s metabolic rate, injection site, and lifestyle factors.

  DermaHub

4. Pharmacokinetic Profile

• Local Retention: The high density and robust cross-linking network anchor the product securely within the subcutaneous architecture, delaying enzymatic breakdown compared to facial-grade low-molecular-weight fillers.

• Metabolism: Degraded gradually through normal physiological hyaluronidase activity and standard metabolic pathways, eventually breaking down into water and carbon dioxide.

5. Physiological Effects and Adverse Event Spectrum

Local tissue reactions are typical of large-volume body filler procedures and generally resolve within a short window.

Adverse Reaction Profile

• Common ($\ge 1/100$ to $<1/10$): Temporary injection site reactions including localized pain, bruising, erythema, edema, tenderness, and firmness.

• Uncommon ($\ge 1/1,000$ to $<1/100$): Transient palpable nodules, localized asymmetry, or prolonged swelling at the deep injection plane.

• Rare / Severe (<1/1,000): Deep tissue infection, sterile abscess formation, delayed hypersensitivity reactions, or vascular compromise secondary to inadvertent intravascular placement.

6. Contraindications, Drug Interactions, and Clinical Precautions

Controindicazioni

• Known hypersensitivity to hyaluronic acid or amide-type local anesthetics (lidocaine).

• Active cutaneous infections, inflammation, or structural skin lesions at or near the target treatment site.

• History of severe systemic allergies, anaphylaxis, or predisposition to hypertrophic scarring and keloid formation.

• Pregnancy and breastfeeding.

Key Interacting Factors & Warnings

• Vascular Safety: Given the high volume and deep subcutaneous placement required for body augmentation, thorough anatomical knowledge and careful aspiration techniques are vital to avoid major blood vessels.

• Aseptic Handling: Must be handled strictly under aseptic conditions; the syringe is designed for single-patient use and must not be resterilized or shared.

  kstation

Clinical Precautions and Post-Treatment Guidelines

• Post-Procedure Care: Advise patients to avoid heavy pressure, intense friction, extreme heat (such as saunas or heavy sun exposure), and strenuous physical exercise or athletic strain on the treated area for at least 1 to 2 weeks post-injection.