SoftFil Topilase® | Topical Hyaluronidase

SoftFil Topilase delivers 150 IU of recombinant hyaluronidase per gram of a patented carbomer–propylene glycol gel. The enzyme is produced in a eukaryotic expression system and purified to > 95 % homogeneity, ensuring minimal immunogenic contaminants. The gel’s pH is buffered at 7.2 to preserve enzyme activity upon topical application, and excipients include glycerin for hydration and a penetrant enhancer to facilitate stratum corneum diffusion. Microbiological validation confirms sterility, and endotoxin levels remain below 0.1 EU/mg. Preformulation studies demonstrate that > 80 % of the enzyme remains catalytically active for at least six months at 4 °C, providing a stable topical solution for ambulatory use. sample

SoftFil Topilase is indicated for the management of superficial hyaluronic-acid filler irregularities—small nodules, bumps or visible Tyndall effect—as well as for accelerating the resolution of post-procedural ecchymosis and transient edema. Ideal candidates have small, palpable HA deposits within 1–2 mm of the epidermis or bruises from needle trauma. Because the enzyme acts by cleaving β-1,4 glycosidic bonds in HA, application over the lesion dissolves superficial gel without affecting deeper, properly placed filler. It also helps resolve mild hematomas by breaking down endogenous HA in perivascular spaces, improving lymphatic clearance. Contra-indications include broken skin, active dermatitis, known hypersensitivity to hyaluronidase or any excipient, and open wounds. s

Each SoftFil Topilase kit contains:
* 1 × 10 g tube of gel (inner foil-lined, pharmacy-grade aluminum)
* 1 × sterile applicator spatula for hygienic dosing
* 1 × peel-off traceability label for patient records
* 1 × printed dosing chart indicating application frequency and volume per lesion

All components are latex-free and comply with ISO 10993 biocompatibility standards. The tube and packaging use recyclable materials, and the product carries a 24-month unopened shelf life when stored at 2–8 °C.

Clinical experience shows SoftFil Topilase begins to soften superficial HA nodules within 4–8 hours of the first application. Visible reduction in bump size occurs after 1–2 days of twice-daily use, with complete resolution in most cases by day 3–5. Bruising and edema similarly improve, with significant color fading and decreased swelling within 48 hours. Maintenance applications beyond day 5 are rarely needed, but can be repeated up to three times for large or recalcitrant lesions. The non-invasive nature of the gel allows uninterrupted daily activities and no observable downtime.

Q1: How often should I apply the gel?
A1: Apply a 0.5 cm ribbon over the lesion twice daily (morning and evening) for up to 5 days.

Q2: Can I use it under makeup?
A2: Yes—once the gel absorbs (≈10 minutes), you may apply light cosmetics; avoid occlusive products.

Q3: Will it affect correctly placed deep filler?
A3: No—topical penetration is limited to the superficial dermis; deeper filler (> 2 mm) remains intact.

SoftFil Topilase is developed and manufactured by Dermabio Pharmaceuticals, an ISO 13485-certified biotech based in Basel, Switzerland. Production occurs in GMP-compliant cleanrooms, with each lot undergoing HPLC enzyme-activity assays, endotoxin testing, and microbial challenge before release. Dermabio’s sustainability program includes solvent-recycling processes and 50 % recycled polymer in secondary packaging, with a roadmap to carbon neutrality by 2030. SoftFil Topilase is distributed worldwide through licensed medical-aesthetic practitioners and pharmacies.