Hyaluronic acid filler / Galderma
Restylane Kysse
A lip-specific HA formulation and a comparative trial that keeps volume and outcome separate.
Product Atlas · September 2026
The exact product comes first
Scope of this monograph#
Restylane Kysse, US IFU. The older European comparative study evaluated its named study formulations.
Clinical statements below summarize the attached documents. They are not a complete prescribing label. Match the exact local product and current instructions to the clinical decision.
Composition & formulation#
BDDE-crosslinked sodium hyaluronate, 20 mg/mL, with lidocaine hydrochloride 3 mg/mL in buffered saline.[2]
How it works#
The flexible viscoelastic gel augments tissue volume; lidocaine reduces injection discomfort.[2]
Indications & treatment areas#
The US IFU covers lip augmentation and correction of upper perioral rhytids in patients over 21.[2]
Application considerations#
A single-patient, single-session product, used as supplied by a trained practitioner. Lip vascular anatomy and previous surgery require assessment.[2]
Contraindications & precautions#
Severe allergies, gram-positive bacterial-protein hypersensitivity, and lidocaine or other amide-anaesthetic allergy are contraindications. Defer active inflammation or infection.[2]
Adverse effects & safety#
Swelling, tenderness and bruising may occur. Delayed inflammatory papules and vascular occlusion are important risks; visual symptoms need urgent evaluation.[2]
Duration & follow-up#
The US study followed participants through week 48. A separate small comparative trial measured lip fullness and aesthetic improvement at different timepoints.[2][3]
Distinctions that matter#
The comparative study used less mean volume for HA-RK than HA-JV, but small-study averages are neither a dose guide nor a general ranking.[3]
Four markets. Separate evidence.#
Documents below identify what has been attached in this research edition. “Source needed” means unverified here; it is not a statement that a product is unapproved.
A current, exact-product local label or regulatory record has not yet been reconciled in this edition. Regulatory status is unverified here.
Contribute a local source ↗A current, exact-product local label or regulatory record has not yet been reconciled in this edition. Regulatory status is unverified here.
Contribute a local source ↗US-specific instructions attached. A Canadian or European IFU must not substitute for this document.[2]
ARTG 235986 identifies Q-Med AB as manufacturer and Galderma Australia as sponsor. Local indication and application wording still requires the Australian IFU.[1]
Studies worth a closer look.#
Less volume is not a universal dosing rule.
Keep lip fullness, aesthetic improvement and injected volume as separate measurements.
Follow the evidence.#
Retrieved 6 September 2026. A retrieval date does not establish that an older document is the latest approved revision. Studies marked “abstract” have not completed full-text appraisal.
- [1] Restylane Kysse — ARTG 235986 ↗Therapeutic Goods Administration · regulator · Document accessed · Checked 2026-09-06
- [2] Restylane Kysse US instructions for use ↗Galderma · label · Document accessed · Checked 2026-09-06
- [3] Hilton et al. — two HA gels for lip enhancement ↗Dermatologic Surgery, 2018 · PMID 29059146 · study · Abstract accessed · Checked 2026-09-06
Cite this monograph#
Aesthetic Pass. Restylane Kysse. Product Atlas research edition 2026.09.06.1. https://aestheticpass.com/products/monographs/restylane-kysse/