Treatment Guidelines

Transcription

1 Treatment Guidelines Cutera Inc. World Headquarters 3240 Bayshore Boulevard, Brisbane, CA USA Tel: Fax:

2 The Cutera, Inc. Prowave LX handpiece is indicated for the removal of unwanted hair, and to effect stable, longterm, or permanent, hair reduction PREREQUISITE The Prowave LX handpiece should only be operated by qualified practitioners who have received appropriate training and have thoroughly reviewed the Operator Manual prior to operating the Prowave LX handpiece. SPECIFICATIONS Spot size: 1x3 cm Wavelength: 680 nm to 1100 nm o Automatically set by Program Mode Fluence: 5 to 35 J/cm² o Operator selects Rep Rate: 0 to 2.0 Hz o Operator selects LASER HAIR REMOVAL PROCESS The purpose of the treatment is to selectively treat the hair follicle without causing thermal damage to the surrounding tissue. o The sapphire window provides epidermal cooling and protection. Permanent hair reduction is achieved by using heat to disable the hair follicle and prevent re-growth o The bulb and bulge of the hair follicle, which are responsible for hair re-growth, are targeted by the Prowave LX. o Because the bulb and bulge of the hair follicle must be present, do not pluck or wax targeted hair in between treatment sessions. The Prowave LX targets the melanin in the hair bulb and bulge; therefore hair must be brown or black. o The Prowave LX does not target and cannot be absorbed by white, gray, red or light-blond hair. 2

3 HAIR GROWTH PHASES Anagen - Active Phase o The laser light is absorbed by the melanin in the hair shaft reaching bulb and disabling the hair follicle Catagen - Transitional Phase o Hair bulge & bulb are beginning to disengage from the hair shaft and treatment is not effective Telogen - Resting Phase o Hair bulge and bulb are disengaged from the hair shaft and treatment is not effective TREATMENT INTERVALS Only the hair follicle in the anagen growth phase can be effectively targeted and disabled Multiple treatments are required to achieve sufficient reduction in hair growth because each hair goes through 3 growth phases (anagen, catagen and telogen) independent of the neighboring hairs so not all hairs will be in the same phase at the same time, thus multiple treatments are required Treatment Interval recommendations are a general guideline only and are a compilation of intervals used by successful operators o Facial hair: 6-8 week intervals between treatments o Body hair: 8-10 week intervals between treatments o Back or Leg hair: week intervals between treatments Hormones, diseases, medication or other factors can affect the treatment outcome Treatments that are spaced too close together may appear to be more successful within the first few treatments but a smaller percentage of anagen hair may be available as a target thus more treatment sessions may be required for the desired final outcome Patients should be assessed before each treatment to determine treatment intervals and settings o Hair may grow back lighter and finer and settings may need to be adjusted to target this new hair If the patient returns for treatment and there is minimal hair, it may be in a transitional or resting phase o Wait until hair is actively growing to resume treatment cycle Facial skin has significantly more hair follicles at per cm2 than the body which is why you can see results within the first three to four treatments with shorter interval times When in doubt, it is better to space the treatments farther apart than closer together 3

4 PATIENT ASSESSMENT Contraindications: Pregnancy and Skin Cancer This is a medical device. It is important to obtain a complete medical history and signed informed consent Determine ethnicity and skin type by using the attached Fitzpatrick Skin Type scale Patient Considerations including but not limited to are below 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 Anticoagulants may increase risk of purpura or bruising Vitiligo may cause de-pigmentation Herpes pre-treatment with an antiviral may be indicated Open wounds History of keloid or hypertrophic scarring Patients with Hormone disorders (i.e.polycystic Ovarian Syndrome) may not see effective hair reduction Only treat over known benign lesions Do not treat over dysplastic nevi or questionable pigmented lesions o Online Melanoma resources include ( ( AVOIDING COMPLICATIONS Extreme caution should be used when treating near the eye. o Always treat outside the orbital rim of the eye aiming the beam away from the orbit o Patient eye protection should be always be used. o The treatment window should be pointed away from the eye and applied to the skin outside of the orbital rim. o Skin at the edge of the orbital rim can be treated by pulling it away from the eye while simultaneously holding the goggles in place, so treatment is kept outside of the orbital rim. Do not treat over or close to tattoos or permanent make-up Shave treatment area Sun exposure, tanning beds or artificial tanning may increase risk of side effects and adverse events No self-tanners or sun-tanning for at least 4 weeks prior to treatment o Includes spray tans, tanning lotions, tanning beds, sun exposure, etc. o Self-tanners need to be completely sloughed and this can take up to 4 weeks o Patient should have no residual suntan (sun/tanning booth) prior to treatment o Sun tan should be faded but keep in mind that any residual tan is a target for the laser All traces of make-up must be removed Be aware of implants and threads Stay at least 6 inches away when treating near a Pacemaker Reaction to fillers unknown Pigmented lesions may darken. Allow these to slough off naturally. Avoid treatments that may irritate the skin for 1-2 weeks prior to treatment (depilatories, harsh chemicals, etc.) Ensure the entire sapphire crystal is in full contact with the skin during the treatment. Cold gel packs or cool compresses can be used post-treatment for patient comfort. Ice should not be applied directly to a suspected burn as it may cause unwanted side effects. Ensure treatments are not spaced too close together as this will decrease efficacy of treatment 4

5 PREPARING THE PATIENT Clean skin removing all make-up and/or topical anesthetic. Ensure treatment area is clean shaven. Pre-operative photographs should be taken prior to the initial treatment for future reference. Treatment of a test area should be performed and observed prior to treatment. Potential adverse reactions may take hours to appear. o Foot-printing is usually evident hours post treatment and is not a desirable result; indicates over-treatment. If this occurs, settings should be lowered for desired results. o Patients with actinic bronzing have a higher risk of developing foot-printing. o Test spots should be done on the same area being treated (i.e. don t test spot on arm when treating the face) o Tests spots are recommended prior to subsequent treatments Test spots should include 3-4 adjacent pulses to help gauge skin s reaction to bulk heating Topical anesthetic is optional and must be removed before treating o CAUTION: Toxicity may result from overuse. Consult the manufacturer s labeling. Safety eyewear must be worn by ALL people in the treatment room. o Use eyewear appropriate for Intense Pulsed Light devices ( nm) Shutter Operator Goggles Operator Goggles Patient Goggles Disposable Patient Eye shield 5

6 PROWAVE LX USER INTERFACE 1. Fluence is the energy measured in J/cm2. The lighter the chromophore, the more energy (fluence) is needed. Press the Up/Down arrows to adjust Pulse Duration is the length of each pulse measured in milliseconds (ms). Automatically selected by program. 3. Repetition Rate is the number of pulses per second measured in Hz. Repetition Rate should only be used by advanced users. Slowing down the Repetition Rate can help with patient comfort. Press the Up/Down arrows to adjust Program Selection press the icon underneath the Program Icon to select the appropriate Program Mode. 8 Snowflake Mode ON 5 5. Snowflake Mode is recommended for epidermal protection and patient comfort. Snowflake Mode lowers the treatment window temperature of all Program Modes to 5 C and should be turned on for all treatments. 6. Standby Button press yellow icon to go into Standby Mode. The handpiece cannot be fired when in Standby Mode. Screen background is yellow. Snowflake Mode OFF 7. Ready Button press the green icon to go into Ready Mode to begin treatment. Start the pulse after the flute sound indicates system is ready. Screen background is green. 8. Number of Pluses is displayed. Press the icon to reset. 6

7 PARAMETER SELECTION The following parameters are provided as a guide only and are based on practitioner feedback. Observe lasertissue interaction and clinical endpoints to determine appropriate settings. Short Pulse Duration Mode - most aggressive o Patients with lighter skin types and lighter colored or finer hair Medium Pulse Duration Mode mid-range program o Patients with medium skin types (Skin Types II or III) and medium hair color & thickness Long Pulse Duration Mode least aggressive o Patients with darker skin types (Skin Type III or IV) or actinic bronzing and dark or coarse hair This device is not intended for patients with Skin Type V or VI Actinic Bronzing Patients Actinic bronzing is chronic tan-like pigmentation damage resulting from long-term sun exposure *Caution! Short Mode is not recommended for any patients with actinic bronzing in the treatment area as this short pulse duration mode can remove background pigment Patients with actinic bronzing are at high risks for crusting, foot-printing and adverse events Treating patients with actinic bronzing carries more risks when using the shorter pulse duration modes over the longer pulse duration modes Program Modes Short Mode Short Pulse Duration Mode Medium Mode Medium Pulse Duration Mode Long Mode Long Pulse Duration Mode Short Mode Medium Mode Long Mode Repetition Rate Repetition rate should always be adjusted according to patient tolerance and operator expertise Single pulses are recommended when treating on the face or on contoured area because the crystal must maintain contact with the skin at all times Single pulses are recommended on areas where additional cooling is desired (higher energy settings, sun exposed areas, etc.) Faster repetition rates of Hz are recommended only for experienced practitioners when treating larger areas such as legs, back, arms, etc. o Lower fluences are recommended when treating with faster repetition rates to help prevent heat buildup and potential adverse reactions User slow repetition rate when treating areas of coarse, dense hair Hair Type Fine Hair Medium Hair Coarse Hair Low Density Skin Type I-II Short Mode * Short Mode * Medium Mode J/cm² J/cm² J/cm² Skin Type III Short Mode * Medium Mode Medium Mode J/cm² J/cm² J/cm² Skin Type IV Short Mode * Medium Mode Long Mode J/cm² J/cm² J/cm² Coarse Hair High Density Medium Mode J/cm² Medium Mode J/cm² Long Mode J/cm² Selecting Treatment Parameters Always start with a low fluence and assess patient s skin reaction to determine proper settings o Test spots are important to determine proper settings Treatment ranges are wide due to significant variations in patient response o Caution! Sun exposed areas have a higher risk of adverse events o Important to also assess hair color to determine proper settings o Darker Hair Color = Lower Fluence range o Lighter Hair Color = Higher Fluence range o Men s beards should be treated with lower fluence Pigment and moles in the treatment area may be affected Patients should be re-assessed prior to each treatment to determine sun exposure and hair s density and coarseness 7

8 TREATMENT TECHNIQUE Verify that Snowflake Mode is turned ON (blue) to ensure epidermal protection and patient comfort Hair should be clean shaven Inspect the handpiece to ensure the crystal surface is free of debris and ejected hair prior to and during treatment Apply a thin layer of ultrasound gel for increased epidermal protection and easy gliding of the handpiece to determine placement of adjacent rows Crystal must be in full contact with skin during treatment o Pay particular attention when treating rounded/bony areas Pulses should be placed adjacent to one another with no overlap Common endpoints are mild to moderate erythema and/or peri-follicular edema, though these endpoints are not required for a successful treatment and are usually delayed o If treated area darkens or develops significant erythema or edema, the fluence should be decreased or switch to longer pulse duration mode (i.e. from Short Mode to Medium Mode or from Medium Mode to Long Mode) If desired clinical endpoint is not achieved, consider increasing fluence or move to a more aggressive pulse duration mode Always observe the epidermis during the treatment, watching for signs of damage (epidermal separation or gray coloration) o If damage is seen, stop the treatment and cool the skin and evaluate area for possible complications and wound care Areas of different density may require adjusting settings during the same treatment o Use caution on men s neck as the hair line is approached Be extra cautions when treating unusual areas (i.e. scalp hair, knuckles, men s genitalia, ears, inside nose, etc.) o Provide extra cooling with handpiece and/or frozen gel pack Higher hair density may absorb more heat Thinner skin is more easily damaged o Insert damp cotton ball inside ear canal o Pull skin away from testes to treat Do not double-pulse or retreat an area within a single visit When treating near the mouth, rolled-up gauze can be placed between the lips and teeth to protect teeth from discomfort Correct Technique Incorrect Techniques 8

9 POST TREATMENT CARE For best results, ensure patient adheres to post-care instructions: Avoid sun exposure and use a broad spectrum (UVA/UVB) sunscreen Redness and peri-follicular edema (looks like a rash/bug bites) are common and resolve with time Bruising and swelling are less common but may occur and will resolve with time Hair may take up to 2 weeks to fall out Avoid heat hot tubs, saunas, etc. for 1-2 days Avoid skin irritants (examples below) a few days post-treatment o Products containing tretinoin, retinol, benzoyl peroxide, glycolic/salicylic acids, astringents, etc. Do not wax or pluck between treatments SAFETY & SYSTEM MAINTENANCE Log on to the Clinical & Training section of the Cutera website s Education tab ( for important information on Laser Safety and Laser Physics o These presentations review light-tissue interaction and safe laser practices 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 9

10 Fitzpatrick Classification Questionnaire SCORE What is the natural color of your hair? Sandy red Blond Chestnut, dark blond Dark brown Black What is the eye color? Light blue, Gray, Green Blue, Gray, Green Blue Dark Brown Brownish Black What is the color of sun unexposed skin areas? Reddish Very pale Pale with beige tint Light brown Dark brown How many freckles on unexposed skin areas? What happens when you are in the sun TOO long without sunblock? Many Several Few Incidental None Painful redness, blistering, peeling Blistering followed by peeling Burns, sometimes followed by peeling Rarely burns Never had a problem How well do you turn brown? Hardly or not at all Light color tan Reasonable tan Tan very easily Turn dark very quickly Do you turn brown within one day of sun exposure? Never Seldom Sometimes Often Always How does your face respond to the sun? Very sensitive Sensitive Normal Very resistant Never had a problem When did you last expose yourself to the sun or artificial sun treatments? More than 3 months ago 2-3 month ago 1-2 months ago Less than 1 month ago Less than 2 weeks ago Do you expose the area to be treated to the sun? Never Hardly ever Sometimes Often Always TOTAL points = Skin type I points = Skin type II points = Skin type III points = Skin type IV points = Skin type V & VI 10