VariLite Treatment Guidelines

Transcription

1 VariLite Treatment Guidelines Cutera Inc. World Headquarters 3240 Bayshore Boulevard, Brisbane, CA USA Tel: Fax: D1355 RevB June2013 p. 1

2 The Cutera VariLite is a dual wavelength (532 nm and 940 nm) laser system which comes standard with two interchangeable handpieces; the 0.7 mm and handpieces. The handpieces are dual wavelength, allowing convenient switching between wavelengths during a treatment session. The Cutera VariLite laser is indicated for the treatment of: Vascular lesions Benign pigmented lesions Cutaneous lesions Hair removal Treatment of moderate inflammatory acne vulgaris. MECHANISMS OF ACTION The VariLite treats vascular lesions, pigmentation and cutaneous lesions by selectively targeting hemoglobin and melanin (selective photothermolysis). Vascular lesion treatments - Laser light is absorbed by hemoglobin in the vessels and the heat produced causes photocoagulation. Heat is transferred to the vessel wall which ultimately destroys the vessels and prevents recanalization. The laser treats individual vessels but new vessels may appear over time due to an underlying disorder. Benign pigmented lesion treatments - Laser light is absorbed by superficial melanin in the lesion. Pigmented cells are denatured, darken, rise to the surface and flake off over several weeks. Cutaneous lesion treatments Laser light is absorbed by melanin in the lesions and/or hemoglobin in the feeder vessels for the lesion. Heat is added by successive pulses raising the temperature of the lesion to reach the desired clinical endpoint. The VariLite treats hair by selectively treating the hair follicle Laser light is absorbed by melanin, which is the target (chromophore) in hair. The light is converted to heat. Heat damages the bulge and bulb, disabling the hair structure. VariLite treatment of moderate inflammatory acne vulgaris Current literature suggests that primary method of action is 532 nm photo-activation of endogenous porphyrins produced by P-acne (Propionibacterium acne) bacteria. The activated porphyrins reduce the bacteria count diminishing acne severity. It has also been suggested that thermal effects of laser treatment suppress sebaceous gland activity reducing sebum production. D1355 RevB June2013 p. 2

3 Optional Accessory ClearView 3 The ClearView 3 headset is an all-in-one solution to eye safety, magnified vision, and cross polarization illumination during laser treatments for vascular, pigmented and cutaneous lesions. Lightweight headset with adjustable headband 2.3x magnification surgical loupes Combines adjustable polarization with illumination Enhances visualization of subsurface structures Eye safety filters provide protection against 532 nm, 940 nm, and 1064nm laser light Optional Handpieces 1.4 mm spot size 2.0 mm spot size D1355 RevB June2013 p. 3

4 PREREQUISITE The VariLite device should only be operated by qualified practitioners who have received appropriate training and have thoroughly read the VariLite Operator Manual (shipped with laser). PATIENT ASSESSMENT This is a medical device. It is important to obtain a complete medical history and signed informed consent. Consult the Operator Manual for additional information, including expected transient events and possible adverse events. Contraindications: Pregnancy and patients undergoing treatment for skin cancer Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Re-evaluate patient prior to each treatment Sun exposure may increase melanin content of the skin; treatment settings may need to be adjusted Patient Considerations Current Medications (both routine and occasional use) o Accutane do not treat if taken in the last 6 months o Gold Therapy may cause blue-gray discoloration o Photosensitizing drugs (Tetracycline, etc) perform test spots and adjust parameters accordingly o Anticoagulants may increase risk of purpura or bruising Vitiligo heat from the treatment could induce a flare-up Herpes heat from the treatment could induce a flare-up. Pre-treatment with an antiviral may be indicated Wound infections History of keloid or hypertrophic scarring Diabetes may impede wound healing Do not treat dysplastic nevi or questionable pigmented lesions o Online melanoma resources include ( ( Use caution when treating over hair bearing areas. Laser energy may affect hair growth D1355 RevB June2013 p. 4

5 AVOIDING COMPLICATIONS Darker skin types have an increased risk of complications and/or pigmentary issues Only treat over known benign lesions Do not treat over dysplastic nevi or questionable pigmented lesions o Online Melanoma resources include ( ( Always treat outside the orbital rim of the eye aiming the beam away from the orbit Do not treat over or close to tattoos or permanent makeup Reaction to fillers unknown Sun exposure, tanning beds or artificial tanning may increase risk of side effects and adverse events No self-tanners for at least 2-4 weeks prior to treatment Moist gauze may be placed between the lips and teeth to protect tooth enamel If epidermal blanching is observed, reduce overlap, reduce fluence, or reduce repetition rate PRETREATMENT PREPARATION Safety eyewear appropriate for 532nm & 940 nm must be worn by ALL people in treatment room. o The laser ships with opaque stainless steel patient goggles as well as operator goggles o Check the wavelength and optical density (>= 532nm and 940nm) marked on all operator goggles Topical anesthetic is optional. Remove before treating o CAUTION: Toxicity may result from overuse. Consult the manufacturer s labeling. Skin cooling prior to or during treatment is not required for VariLite treatments Clean skin removing all make-up and/or topical anesthetic Shave the treatment site if there is excessive hair Pre-operative photographs should be taken prior to the initial treatment for future reference o SELECTING PARAMETERS Wavelength (nm) o Choice of 532 nm or 940 nm Fluence (J/cm²) o Energy measured in J/cm 2 o Darker skin types may require lower fluence Pulse duration (ms) o Length of each pulse measured in milliseconds (ms) o Synchronized with fluence but can be lengthened separately for a more conservative treatment Repetition Rate (Hz) o Number of pulses per second when foot pedal is depressed measured in Hz o 3-6 Hz for 532 nm o 2-3 Hz for 940 nm o Novice operators should choose lower Repetition Rate o Moving too slowly will increase the overlap o Moving too fast may leave skip areas Treatment Technique o Handpiece should be held approximately 15 from perpendicular to skin o Adjust aiming beam to desired intensity Move the handpiece in a steady fashion appropriate for the repetition rate D1355 RevB June2013 p. 5

6 VASCULAR TREATMENTS The recommended parameters are provided as a guide and are based on practitioner feedback. Choose the lowest fluence that reaches the desired clinical endpoint in a single pulse. Indication Wavelength Spot Size Fluence Fine Red Telangiectasia 532 nm 0.7 mm 18 J/cm² - 22 J/cm² 15 J/cm² - 18 J/cm² Medium Red Telangiectasia 532 nm 0.7 mm 19 J/cm² - 24 J/cm² 16 J/cm² - 20 J/cm² 940 nm 940 nm 0.7 mm Large Red Telangiectasia 940 nm 0.7 mm 280 J/cm² J/cm² 180 J/cm² J/cm 200 J/cm² J/cm² 140 J/cm² J/cm 2 Purple/Blue Vessels 940 nm 180 J/cm² J/cm² Cherry Angiomas Small/Moderate Large 532 nm 940 nm 0.7 mm 0.7 mm 18 J/cm² - 24 J/cm² 14 J/cm² - 18 J/cm² 200 J/cm² J/cm² 180 J/cm² J/cm² Treatment Steps Red Telangiectasia o 532 nm wavelength recommended for vessels < 200 microns, 940 nm recommended for vessels > 350 microns o Apply a thin layer of clear water-based gel to the treatment area o Overlap pulses by no more than 20% with 532 nm, and space pulses by 20% or greater with 940 nm treatments o Choose a fluence that reaches the desired clinical endpoint is a single pulse o Endpoint is immediate vessel disappearance without epidermal blanching o Allow for cooling time before retreating the same vessel Purple/Blue Spider Veins o 940 nm wavelength recommended o Apply a thin layer of clear water-based gel to the treatment area o Separate exposures by 20%. Avoid overlapping pulses o Deliver 2-3 pulses at a time to minimize treatment discomfort o Endpoint is color change or constriction of the vessel without epidermal blanching o Allow for cooling time before retreating the same vessel Cherry Angiomas o 532 nm is recommended for most lesions. 940 nm is recommended large elevated body lesions o Gel is not required o Overlap pulses by 10 to 20% o The lesion with turn brown/gray with each exposure. The desired endpoint is no red remaining Vascular Treatment Intervals o Recommended time interval between treatments is 4-6 weeks, depending on rate of clearance D1355 RevB June2013 p. 6

7 BENIGN PIGMENTED LESIONS The recommended parameters are provided as a guide and are based on practitioner feedback Indication Wavelength Spot Size Fluence Light Lentigines 532 nm 0.7 mm 20 J/cm² - 30 J/cm² 23 J/cm² - 27 J/cm² Medium Lentigines 532 nm 0.7 mm 14 J/cm² - 20 J/cm² 14 J/cm² - 20 J/cm² Dark Lentigines 532 nm 0.7 mm 9 J/cm² - 14 J/cm² 6 J/cm² - 12 J/cm² DPN (Dermatosis Papillosa Nigra) 532 nm 0.7 mm 9 J/cm 2-12 J/cm 2 7 J/cm² - 10 J/cm² Treatment Steps Benign Pigmented Lesions - o 532 nm wavelength recommended o Gel is not used o Lighter lesions require more fluence and darker lesions require less fluence o For smaller lesions, deliver pulses adjacent to each other as you move across lesion o For larger lesions, first circumscribe the perimeter overlap pulses slightly (defining the lesions margin), and then treat the center of the lesions with pulses slightly seperated o Dark lesions may pop during treatment o The endpoint is slight darkening or graying of the lesion Lesion will darken and crust with time If endpoint not reached, increase fluence, allow cooling time & retreat Treatment Intervals o Recommended time interval between treatments is 4-6 weeks, depending on rate of clearance o Treated lesions should have sloughed and be fully healed before next treatment D1355 RevB June2013 p. 7

8 CUTANEOUS LESIONS The recommended parameters are provided as a guide and are based on practitioner feedback Indication Wavelength Spot Size Fluence Skin Tag 532 nm 0.7 mm 16 J/cm² - 20 J/cm² 14 J/cm² - 16 J/cm² Verruca 532 nm 0.7 mm 20 J/cm² - 24 J/cm² 15 J/cm² - 20 J/cm² Seborheic Keratosis < 1 mm thick Seborheic Keratosis > 1 mm thick 532 nm 940 nm 0.7 mm 16 J/cm² - 25 J/cm² 14 J/cm² - 20 J/cm² 200 J/cm² J/cm² Sebaceous Hyperplasia 532 nm 0.7 mm 16 J/cm² - 20 J/cm² 14 J/cm² - 16 J/cm² Treatment Steps General information o 532 nm is recommend except for thickened (>1 mm) SK s o Heat is added by successive pulses raising the temperature of the lesion to reach the desired clinical endpoint o To increase thermal effects, more overlap is recommend than typical with vascular or pigmentation treatments. Lower fluence with more overlap may improve outcome. o Overlap pulses by at least 50% o The end point for cutaneous lesion treatment is a frosting or graying of the lesion o If endpoint is not reached, increase overlap and/or increase fluence Skin Tags o Treat the circumference of the base of the lesion o Endpoint is a graying or frosting of the lesion including the base Verruca o Smaller diameter (< 7 mm) thin (< 1mm thick) lesions are more responsive o Stack 2-3 pulses if need to achieve clinical endpoint o Endpoint is a frosting of the lesion Seborheic Keratosis o Smaller thin lesions respond like pigmented lesions (darkening, crusting, slough) o Larger thicker lesions are less responsive and may require heating with 940 nm in addition to 532 nm o Endpoint is a darkening or frosting of the lesion o Sebaceous Hyperplasia o Stack 2-3 pulses if need to achieve clinical endpoint o Endpoint is a shrinkage or frosting of the lesion o A superficial crust may develop and slough 5 to 10 days after treatment o Lesions will be reduced in size, not removed D1355 RevB June2013 p. 8

9 HAIR REMOVAL The recommended parameters are provided as a guide and are based on practitioner feedback Indication Wavelength Spot Size Fluence Dark, coarse hair 940 nm 2.0 mm 40 J/cm² - 60 J/cm² Medium hair 940 nm 2.0 mm 50 J/cm² - 80 J/cm² Light, fine hair 940 nm 2.0 mm 70 J/cm² J/cm² Treatment Steps Hair Removal - o 940 nm wavelength recommended o Use only for treatment of individual hairs o Apply a thin layer of clear water-based gel o Cooling (Zimmer, ice pack, etc.) can be used for increased epidermal protection o Hair reduction is dependent on hair growth cycle of the hair (anagen, catagen or telogen) and multiple treatments are required Details about laser hair treatments can be found online at - Treatment Guidelines o Hair must be brown or black for an efficacious treatment Blonde, grey, white or red hair will not respond to laser treatments ACNE The recommended parameters are provided as a guide and are based on practitioner feedback Indication Wavelength Spot Size Repetition Fluence Rate Moderate inflammatory acne vulgaris 532 nm 0.7 mm handpiece defocused to a 10 mm treatment spot 15 Hz 24 J/cm² Treatment Steps Moderate Inflammatory Acne Vulgaris o 532 nm wavelength recommended o Do not apply gel o Defocus the beam by holding the handpiece 10 to 15 cm away from the skin Laser aiming beam should be about 1 cm in diameter (size of a dime) o Move the handpiece in a zig zig motion over a 3 x 3 area of the skin using steady controlled movements spending a little more time over affected skin o It is very important to keep the handpiece in motion to prevent heat build-up and discomfort o The patient should report only mild warming, not discomfort o Yellow florescence will be visible from activated protoporphyrin IX o Following treatment, mild erythema may develop in the treatment area No immediate color change in lesions will be apparent If pain is reported or epidermal blanching is seen, increase handpiece movement speed and/or increase the size of the scan area o Treatments can be repeated weekly or bi-weekly for 3-5 weeks D1355 RevB June2013 p. 9

10 POSTOPERATIVE CARE If blister develops, treat as a wound Cool compresses, chilled gel, etc. may be applied post-treatment as needed for patient comfort Benign pigmented lesions usually darken over the next hours, and crusting begins to form within a few days o This crusting usually resolves in 1 to 3 weeks. It should be allowed to naturally slough for best results Localized erythema and/or edema may also be present and typically resolves within 24 to 72 hours Patients should wear sunscreen and avoid artificial tanning and sun exposure LASER SAFETY AND MAINTENANCE It is important to properly maintain your system. Failure to do so may affect the life of your laser. Review the Operator Manual thoroughly for detailed instructions. Log on to the Clinical & Training section of the Cutera website s Education tab ( for important information on Laser Safety and Laser Physics. These presentations review light-tissue interaction and safe laser practices D1355 RevB June2013 p. 10