RESTYLANE clinical hints

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BACKGROUND Beauty is characterised by A youthful face Facial attractiveness with regards to symmetry and harmony Curves in appropriate places on the face to create interest and light reflection Healthy, clear skin Smooth lips with subtle volume, balance and symmetry Even skin tone and texture. Ageing is inevitable and encompasses both intrinsic and extrinsic factors. Changes occur in the face which can be addressed to some degree by fillers and muscle relaxers such as Dysport. Facial contouring with NASHA gel can be strategically placed to recreate anatomical harmony and restore volume loss. AIM OF TREATMENT NASHA fillers can be used to restore facial volume, which depletes over time, creating a more youthful and enhanced facial appearance while Dysport can be administered to restore smoother facial appearance in the glabella region. There are many methods used to assess the face. One of the methods is by using Phi to determine the most appropriate relationship of various facial structures eg. Lips upper to lower lip ratio of 1:1.618. A more youthful patient presents with a fuller mid face and smooth peri-oral region. The youthful triangle becomes squared off with ageing. Therefore the treatment focus is on elevating malar and zygomatic regions, in conjunction with treatment of the peri-oral and prejowl area to recreate facial harmony. This image shows Phi applied to the face. It depicts the perfect face as an oval which is indicative of an inverted egg shape. The harmonious face has well proportioned eyes, nose and mouth and is a pleasing balanced oval. The Golden Ratio appears extensively in the human face and defines our perceptions of beauty. SUITABLE PATIENT The most suitable patient is healthy and meets the inclusion criteria for Restylane and Dysport and seeks restoration of volume and a smoother facial appearance. The best candidate will have mild to moderate volume loss and reasonably good skin elasticity. INDICATIONS There are two options within the 30 Minute Restore package depending on the volume loss and needs of your patient. Option 1: 2 x 1mL Restylane Perlane with lidocaine 1 x 1mL Restylane with lidocaine 50 units of Dysport 1 x Restylane Recover Cream Option 2: 1 x 2mL SubQ with lidocaine 1 x 1mL Restylane with lidocaine 50 units of Dysport 1 x Restylane Recover Cream Smooth wrinkles with Dysport (Anti-Wrinkle treatment) or Restylane (Dermal Filler products) Restore volume with Restylane (Dermal Filler products) to provide a more youthful appearance Soften lines and reduce the appearance of wrinkles and lines with Restylane (Dermal Filler products) Image 1 Image 2

ADVANTAGES A combination package that offers 3mLs of NASHA Filler for volume restoration to create a 'wow' effect at a reasonable investment. An opportunity to create significant lift and smooth transition in the mid face i.e. recreate the Ogee curve with Restylane SubQ and Perlane. NASHA technology allows Perlane to deliver superior lifting capacity in a high strength, long lasting gel (David Stocks et al, 2011) A highly versatile volume filler for a range of indications. Sub Q is an ultimate dermal filler for maximum lift and structure in areas such as cheeks and jawline. Image 4. Facial Aging Coleman SR. Structural Fat Grafting. St Louis, MO: Quality Medical Publishing 2004. Gosain AK et al. Plast Reconstr Surg 2005; 115: 1143-1152. Image 3 PATIENT ASSESSMENT AND CONSULTATION Photographs prior to treatment are highly recommended When examining the mid face it may be helpful to assess each of the following areas to determine how much volume is required: 1. Tear Trough 2. Lid cheek junction depression 3. Lid cheek junction and malar fat pad depletion. (Haideh Hirmand 2010) Category 2 or 3 patient may require treatment of the mid face first. Explain to the patient the rationale for requiring multi-syringe treatment rather than single syringe. Patients that have multiple areas may require treatment of the mid face first and may need more volume. It is important to explain the rationale for a multi-syringe treatment to the patient. NLF or Marionette fold Different categories based on depth of depression Mild, Moderate, Severe or Extreme. If the patient's NLF or oral commissure is so heavy that you would rate them as severe or exteme then they are best to have treatment of mid face first. Multiple syringes or a combination of treatments may be required. In some cases surgical correction or enhancement may be a better option. For patients where NLF is moderate to severe the patient must understand that if they have a severe fold, one treatment will improve the fold to a moderate category at best. If the fold is in the moderate category, with a re-treatment within 6 months the next treatment may improve it to the mild category. Group Classification Typical Age Description Skin Characteristics I Mild 28-35 No Wrinkles Early photo aging: mild pigment changes, no keratosis, minimal wrinkles, minimal or no makeup. II Moderate 35-50 Wrinkles in Motion III Advanced 50-65 Wrinkles at Rest IV Severe 60 & up Only Wrinkles Richard Glogau, 1996. Early to moderate photo aging: early brown spots visible, keratosis palpable but not visible, parallel smile lines begin to appear, wears some foundation. Advanced photo aging: obvious discolouration, visible capillaries, visible keratosis, wears heavier foundation. Severe photo aging: yellow/grey skin colour, prior skin malignancies, wrinkles throughout no normal skin, cannot wear makeup because it cracks and cakes.

Pix l cannula can be used to create a style of face lifting technique based on superior to inferior and lateral to medial approach. TREATMENT PRINCIPLES: Know your anatomy and be aware that the face is well supplied with blood vessels and nerves. The treatment options can be tailored to the individual patient/client and their needs by adjusting the combination of Restylane products. Cannula or Needle both have a place depending on the skill level of the injector and the aims of treatment. Asepsis is important to prevent introduction of bacteria or contaminants. Lateral to Medial Begin wider out on the lateral aspect of the face and use either Restylane Perlane or Restylane Sub Q and fan in towards the medial aspect of the face using products such as Restylane or Restylane Vital (not included in the 30 minute restore pack). Trigeminal nerve Image 5 Suitable patients would have mild mid face volume loss, combined with mild moderate buccal fat pad loss and mild skin laxity. Commence laterally in front of tragus (beware of the facial nerve and the parotid gland/duct) using a cannula and gentle technique. A minimum of 3 passes of the cannula are required: 1st pass most lateral point to lift using Sub Q or Perlane 2nd pass coming more medial with Perlane or Restylane depending on the degree of buccal hollowing 3rd pass at the corner of the mouth using Restylane (or in patients with finer skin consider Restylane Vital, however this product is not part of the 30 minute restore) filling above the lip and under the lip to replace soft tissue loss and soften upper lip lines. Treating the marionette lines may add volume, so consider the cause of the fold and reduce the weight on the area by supporting points of prominence. Image 6. Sensory innervation of the face. Supratrochlear Supraorbital Lacrimal Zygomaticotemporal Zygomaticofacial Infra orbital Facial Auriculotemporal Buccal Mental (http://www.davidson.edu/academic/psychology/ramirezsite/ neuroscience/psy324/aapatton/anatom4.jpg)

Superior to Inferior Commence treatment for the mid face on the upper segment of the cheek especially if there is moderate malar fat pad loss and/or the patient presents very flat genetically on the zygomatic region. Address the areas of prominence and then the areas in between. Adding too much NASHA gel along the jawline and lower face can add to the heaviness or squaring off of the face. Deep plane to superficial layer Begin with volume filling deep in the subcutis or periosteal layer and work up towards the dermal layers. Use the larger particle size NASHA gel fillers deep and the smaller particle size NASHA gel fillers closer to the dermis. Layer to create a smooth surface without the need to chase rhytids. INJECTION TECHNIQUE Apply headband and remove make up. Determine best placement of NASHA. Sterile or aseptic technique is imperative. Thoroughly cleanse the skin with a suitable antiseptic solution. If using a cannula, local anaesthetic with or without Adrenaline may be medically prescribed for injection at the injection site to ensure comfort, reduce bruising and allow easy entry with the Pix l Cannula. Set up equipment on a sterile dressing pack to avoid contamination of cannula and introduction of bacteria or contaminants. If using a cannula for the injection site: use a needle the same size or slightly larger than the chosen cannula. Take care not to insert the needle too far or to damage a blood vessel with the introducing needle. Carefully introduce the appropriate sized Pix L cannula by rotating and threading the cannula along the upper subcutaneous or hypodermal tissue plane, or in the deep subcutis under the muscle if you are wishing to lift the zygomaticus and malar region. The free hand can be used to manually stretch or support the tissues so that the cannula passes along in the correct plane without bending or requiring undue force. It is important to know the location of the tip of the cannula. Do NOT force the cannula as this may lead to potential bending, weakening or breakage of the cannula. Image 7. Commence treatment in midface and laterally; use cannula or needle to deliver small threads of NASHA gel in a fan like fashion. Suggested treatment areas Malar and zygoma regions (SubQ or Perlane); lip and peri-oral region (Restylane or Lip products - not included in the 30 minute refresh pack); chin (SubQ or Perlane) for the Y lift effect. Other areas that can be treated include the brows (Perlane), lateral aspect of the face (Perlane), the angle of the jaw (SubQ or Perlane), the nose (Perlane), marionettes (Perlane). Restylane can be delivered using linear threading, fanning or Fern Pattern (Dr Tom Van Eijk) technique. Insert the needle and inject a small amount of NASHA gel and wait 5 10 seconds. Slowly advance the needle, injecting in an ante-grade method to allow the Lidocaine to take effect ahead of the needle.

Reconstitute Dysport using 2.5mLs Normal Saline for injection as instructed in the PI. The recommended dose for glabella is 50 Dysport units which equates to 0.25mL volume. Dysport is generally injected deep into the procerus and the medial corrugator muscles and more superficially into the lateral corrugator where it inserts into the dermis, while using a 29g, 30g or smaller needle to minimise trauma and discomfort. Refer to Dysport PI and glabellar treatment guide for more specific details. BEFORE AND AFTER PHOTOS Patient 1 Frontalis Procerus Corrugator supercilii Depressor supercilii Orbicularis oculi Image 8. Recommended injection points (Illustration by Dr Lavent Efe for IPSEN Pty Ltd) Before treatment Patient 2 7 days after 30 Minute Restore Treatment AFTER CARE INSTRUCTIONS As for all Restylane treatments Cool, Calm and Clear Ensure the face is clean and patient does not touch injection sites during the immediate post treatment phase Avoid skin irritants during the first 24 48 hours post treatment. REFERENCES 1. Hirmand, Haideh (2010) Anatomy and Nonsurgical Correction of the Tear Trough Deformity PRS Journal 125(2): 699-708. 2. Q-Med Restylane PI. 3. Stocks, David et al. (2011) Rheological Evaluation of the Physical Properties of Hyaluronic Acid Dermal Fillers. J Drugs Dermatol 10(9): 974-980. 4. Glogau R.G. (1996) Aesthetic and Anatomical Analysis of the Aging Skin. Seminars in Cutaneous Medicine and Surgery. 15(3): 134-138. 5. Coleman, S. & Grover, R. (2006) The Anatomy of the Aging Face: Volume Loss and Changes in 3-dimensional Topography. Aesthet Surg j. 2006; Jan-Feb (1S): S4-9. Image 9 Before treatment 7 days after 30 Minute Restore Treatment These photographs have not been re-touched and have been taken in the exact same lighting. Each patient has had a 30 Minute Restore treatment consisting of 3mls of Restylane dermal filler products and 50 units of Dysport anti-wrinkle treatment. Individual results may vary.

PBS Information 500U vial, 300U vial: Spasmodic torticollis, cerebral palsy spasticity (equinus foot deformity), post stroke spasticity of the upper limb, blepharospasm, hemifacial spasm: Section 100. Refer to PBS schedule for full information. Glabellar lines: not PBS listed. Before prescribing please refer to full Product Information, which is available from Q-Med. Minimum Product Information Dysport : Clostridium botulinum type A toxin-haemagglutinin complex (300 *, 500 DYSPORT UNITS/vial). Indications: spasticity of the upper limb in adults post-stroke; spasmodic torticollis in adults; dynamic equinus foot deformity due to spasticity in cerebral palsy patients, two years of age or older; blepharospasm in adults; hemifacial spasm in adults; moderate to severe glabellar lines in adults. Contraindications: hypersensitivity to ingredients; myasthenia gravis or Eaton-Lambert (myasthenic) syndrome; infection at proposed injection site. Precautions: Do not exceed recommended dosages and frequencies of administration; adverse effects from toxin distribution to sites remote from the site of administration have been very rarely reported (excessive muscle weakness, dysphagia, aspiration pneumonia that may be fatal): use lowest effective dose and do not exceed recommended dose; use with caution in patients with: breathing and swallowing difficulties, evidence of drug-induced neuromuscular weakness/motor neurone disorders, and prolonged bleeding times; rare occurrence of antibody formation to botulinum toxin; contains small amount of human albumin so the risk of transmission of viral infection cannot be excluded; ready availability of adrenaline injection in cases of anaphylactic reaction; drug interactions with muscle relaxants, aminoglycoside antibiotics and other drugs use such drugs with caution * (see full PI); potential risk of muscle weakness or visual disturbances may temporarily impair ability to drive or operate machinery. * Use in pregnancy only if benefit justifies risk; not recommended in lactation. * Dysport is not therapeutically equivalent to the other botulinum type a toxin preparation available in Australia. Extreme caution is required should it prove necessary to substitute the botulinum type a toxin of one pharmaceutical company by another. Adverse Events: common to very common depending on indication: generalised weakness, fatigue, flu-like syndrome, pain/bruising/swelling/reddening at injection site; dysphagia; weakness of the muscle being injected; accidental injuries/falls; dysphonia; diarrhoea; urinary incontinence; abnormal gait; ptosis; diplopia; dry eyes, tearing; eyelid oedema; headache; facial paresis *, asthenopia *, muscle twitching * see full PI. Dose: The units of Dysport are not interchangeable with other preparations of botulinum type A toxin. Spasticity of upper limb post stroke: 500-1000 units per session, distributed amongst five muscles. Spasmodic torticollis: Initially 250-500 units in divided doses; subsequent doses between 250-1000 units. Cerebral palsy spasticity: Initially 20 units/kg bodyweight (10 units/kg for each calf); subsequent doses titrated between 10-30 units/kg bodyweight, divided between both legs. Dose must not exceed 1000 units per session. * Blepharospasm & hemifacial spasm: Initially 40 units/eye; subsequent dose of 80 units/eye for longer duration to maximum of 120 units/eye. * Glabellar lines: 50 units divided equally among 5 injection sites. Administration: Intramuscular injection for all indications except blepharospasm/hemifacial spasm where it is injected subcutaneously. See full PI for guidance on specific muscle sites to be injected and frequency of administration (different for each indication) and reconstitution instructions for 300U * and 500U vials. Storage: 2 C 8 C. PBS dispensed price: 500U: $644.81; 300U: $361.52. Date of TGA approval: 16 Dec 2010. The full PI is available on request from Q-Med, a Galderma Division,13B Narabang Way, Belrose NSW 2085. Phone 1800 144 944. Restylane is a registered trademark of Galderma Australia Pty Ltd. Dysport is a registered trademark of Ipsen Pty Ltd. This material has been prepared by Galderma Australia Pty Ltd Dysport is distributed for the treatment of moderate to severe glabellar lines by: Galderma Australia Pty Ltd, 13B Narabang Way, Belrose, NSW 2085, Australia. ABN 12 003 976 930 T: 1800 144 944 Q-Med 1212-11 Dec 2012