Consent & Disclosure for “Mini” Non-Invasive Extreme Makeover Preliminary Remarks The “Mini” Non-Invasive Extreme Makeover Program designed to introduce you to some of the new technology available to improve the health and appearance of the skin. It addresses most of the concerns that clients express such as unwanted pigmentation (browns and reds), poor texture, fine wrinkles and sagging. It is a series of 6 treatments performed over a 6-10 week period by Dr. Christian and our Aesthetician. However, It should be used only as an adjunct to well planned skin care program consisting of twice daily cleansing, some form of exfoliation, moisturizing and sun protection. We will review your current program of skin care and work with you to make sure you are using appropriate products for your skin type during the initial consultation. It is important that your skin be healthy before we apply some of the technology to be sure we get rapid healing and the best results. We may determine that your skin needs a month or two of skin care prior to any of the laser or light treatments. We promote primarily the SkinCeutical line of products and these can be purchased from us at a 10% Discount or in a special package we have designed. In addition there may be other products which may reduce the appearance of unwanted pigment and wrinkles or which may enhance the effects of the procedures we will perform. It makes no sense to apply some of the high technology procedures we will be using and not be committed to a daily program of skin care for maintenance and prevention of further damage. Much can be done over time with a daily skin care program especially in terms of moisturizing/hydrating and sun protection. The procedures in the “Mini” Non-Invasive Extreme Makeover program are designed to hasten the improvement of your skin health and appearance but this occurs best when the skin is well hydrated and nourished. We cannot proceed with the “Mini” Makeover without your commitment to a daily skin care program. It should be understood that a single series of treatments is unlikely to achieve the final desired results and that a second or third “Mini” series will most likely be required. This program allows you to see the results of a single series of treatments and then you can decide regarding further treatments. I understand the importance of a daily skin care regimen and I agree to utilize products appropriate to my skin type as recommended by Dr. Christian. If I cannot afford a basic program of skin care products I understand I cannot participate in the “Mini” Non-Invasive Extreme Makeover. Skin Care Products are not included in the cost of the program and in some cases you may need additional products to enhance the results of your program or post treatment care. The cost of these is not included in the program. The initial cost of a supply of basic skin care products may be about $200-$400. ____Initials Page 1 of 10 I have seen Dr. Christian’s PowerPoint Presentation regarding the procedures to be applied including the Diamond Microdermabrasion, “Pixel” Laser Skin Resurfacing, Infrared Skin Tightening and Intense Pulsed Light. ____Initials The Program, Summary (May vary with your needs) Initial Consultation, Digital and UV Light Pictures and review of Your Skin Care Product Program. 1 Diamond Microdermabrasion with Javani Procedure 1 Intense Pulsed Light Treatment of Face for Pigmentation 1 Diamond Microdermabrasion with Javani Procedure 1 “Pixel” Laser Skin Resurfacing of the Face to include 1 Infrared Skin Tightening Procedure. 1 Diamond Microdermabrasion with Javani Procedure ____Initials Expected Results You will learn the basics about skin care and preventive measures. Direct Effect of a series of Diamond Microderms with Javani Improvement in the smoothness and texture of the skin because of efficient removal of the outer dead layer of skin followed by Javani Hydration. Direct Effect of a series of “Pixel” Laser Skin Resurfacing Marked improvement in the appearance of fine wrinkles around the eye and mouth. Marked improvement in the appearance of acne scaring and traumatic scaring. Marked improvement in the smoothness and texture of the skin. Increase over time of Collagen, Elastin and Thickness of Epidermis enhancing the results of the immediate shedding and regrowth of the epidermal layer. Direct Effect of a series of Intense Pulsed Light Improvement in the appearance of brown spots and redness/flushing of face. Direct Effect of a series of Harmony Infrared Skin Tightening Gradual improvement will be seen in sagging of the jowls and the skin of the neck after a series of treatments. Direct Effect of a Long Term Skin Care Program Over the long term there will continue to be some improvement in some of the following areas with a program of daily skin care & not due to the “Pixel” Laser, Intense Pulsed Light or Infrared Skin Tightening. Reduction in the appearance of pigment, brown or dark lesions Page 2 of 10 Reduction in redness, flushing, small vessels, Rosacea The skin will be more even toned and smoother Continued Reduction in the appearance of fine wrinkles Reduction in the occurrence of breakouts and blemishes Increased Collagen, Elastin, thickness of Epidermis Unfortunately, there will be continued sun exposure and progression of the aging process therefore followup procedures and Skin Care Products will be required to sustain improvements of some lesions for the long term. ____Initials The Program, Details Pre Program Diamond Microdermabrasion and Javani Most Clients will have a Diamond Microdermabrasion and Javani Procedure prior to your formal consultation to give you some idea of how profoundly even a single treatment using Medical Grade Techniques can improve the texture and appearance of your skin. At this session Dr. Christian will explain some of the basics of skin care and some pictures will be taken. ____Initials Initial Consultation and Treatment During this consultation, Dr. Christian will review your present Skin Care program and determine your Fitzpatrick Skin Type. More pictures will be taken and the face and body will be examined for “targets” for treatment. A list of these “targets” and our objectives will be made and a preliminary plan for treatment will be formulated. This plan may change depending on how your skin responds as the program progresses. If we feel the skin needs some rest for rejuvenation, we may delay some treatments until the skin is ready for more care. During this period, consistent use of skin care products is critical to allow the skin to renew and repair. If suspicious cancerous lesions are discovered during this consultation, referral to Dermatologist will be made for resolution prior to the treatments. ____Initials Indications Indications For Use of “Pixel” Laser resurfacing A series of “Pixel” Laser procedures assists in the treatment of the following skin conditions: Skin resurfacing for rough skin Treatment of wrinkles around eyes, mouth Some Pigmentation will respond Skin tags Scars including acne scars __Initials Page 3 of 10 Indications For Use of Intense Pulsed Light A series of IPL procedures assists in the treatment of the following skin conditions: Vascular changes, including spider veins, broken capillaries and the redness and flushing associated with Rosacea. Pigmentation changes, including brown/black spots or freckles associated with aging and sun damage. Large pores will be reduced in size and appearance. Improvement in acne and other inflammatory lesions are reduced Some congenital vascular lesions such as hemagiomas Reduction in the redness of old scars Some improvement in fine wrinkles and skin laxity over the long term with continued maintenance treatments several times per year. Some resolution of Actinic Keratoses with use of Levulan. ____Initials Indications For Use of Infrared Skin Tightening A series of Infrared Skin Tightening procedures assists in the treatment of the following skin conditions: Mild to Moderate Sagging and Laxity of the Neck Mild to Moderate Sagging and Laxity of the Cheeks and Jowls. __Initials Contraindications Contraindications For Use of “Pixel” Laser Skin Resurfacing or Intense Pulsed Light or Infrared Skin Tightening These procedures should not be performed if any of the following apply: I am an uncontrolled diabetic and/or subject to poor healing History of Keloid Scar formation Pregnancy Active tanning in the sun or in Tanning Booths/Beds for 4 weeks prior to the treatment. Fitzpatrick Skin Types V and VI. Dark Brown or Black skin Use of Accutane in the 6-9 months prior to the treatment Use of Retin A if irritation and redness is present Use of anticoagulants such as Coumadin or Heparin or large doses of daily aspirin. Botox or Restylane in the prior 2 weeks in the area to be treated. Scleroderma Prior Radiation in the treatment area Open Sores, infection, wounds or uncontrolled Acne. Active herpes simplex (cold sores) or shingles. Use of Sun Sensitizing Medications Suspicion of cancerous lesions. None of these apply ___Initials Page 4 of 10 Mechanisms of Action Mechanism of action of the “Pixel” Laser The “Pixel” Laser Device produces a beam of highly concentrated light at a wave length of 2960nm delivered in a pulse of varied duration and energies. This wavelength is very highly absorbed by water, which is the primary target. Clients with very hydrated skin (dermis and epidermis) will have a more pronounced result. Once the water absorbs the light, it is converted to heat which in turn damages/destroys/vaporizes the undesirable target tissue. A portion of the epidermis will be damaged which then sheds over 5-7 days leaving a smoother texture and fine wrinkles and scars are diminished. The “Pixel” laser will penetrate also into the dermis and heat up water which then denatures collagen leading to the formation of new or remodeled collagen which then over the long term smoothes and tightens the skin. In this procedure the Laser Pulse is divided into either 49 or 81 smaller pulses which only damages a fraction of the skin, leaving much normal skin to aid in the healing process. The body’s natural healing process then occurs and the damaged tissue will flake off over a period of 5-7 days. The settings on the device consist of the duration of the pulse and the energy and are determined by your skin type and the type of target lesions. Initially the settings are on the low side to test how your skin will react to the pulse and at subsequent sessions the settings are increased or adjusted to get maximum results with minimal side effects. A “Conservative” Treatment would entail only a single pass. A “Moderate” Treatment would entail 2 passes in different directions and an “Aggressive” Treatment would entail 2-3 passes with “stacking” of pulses in problem areas. ____Initials Mechanism of action of Intense Pulsed Light The IPL Device produces a broad beam of highly concentrated light delivered in a pulse. This light is filtered to a wavelength that is selectively absorbed by target tissues, (the lesions we want to treat) with hopefully minimal effect of the surrounding skin. Once the target absorbs the light, it is converted to heat which in turn destroys the undesirable target tissue. The body’s natural healing process then absorbs the damaged tissue or the damaged tissue will flake off over a period of days to weeks. The settings on the device consist of the duration of the pulse and the energy and are determined by your skin type and the type of target lesions. Initially the settings are on the low side to test how your skin will react to the pulse and at subsequent sessions the settings are increased or adjusted to get maximum results with minimal side effects. ____Initials Mechanism of action of Infrared Skin Tightening The Infrared device produces a broad beam of highly concentrated light in the Infrared range delivered in a pulse. This light is filtered to a wavelength that is selectively absorbed by water in the dermis producing heating of the water. Once the water is heated, there is denaturing of the collagen with subsequent remodeling which results in some tightening of the overlying skin. These changes occur over time and the final result might not be apparent for 4-6 months after a treatment. This is the time that is needed for collagen remodeling to occur. There will be no shedding of skin with this procedure and it will be done just prior to the “Pixel” Laser Procedure. ____Initials Page 5 of 10 Alternatives to “Pixel” Laser Skin Resurfacing, Intense Pulsed Light and Infrared Skin Tightening I understand that these procedures are used as an adjunct to a comprehensive program of skin care and a prolonged course of these products may achieve some of the desired skin changes I am seeking. I have explored these alternatives to my satisfaction and have made an independent decision to proceed with this series of treatments in the hope that the desired skin changes may be more rapid, effective and more lasting. ____Initials Limitations I understand that some improvement is achieved in nearly everyone, but that my results and/or complete resolution of the undesirable target lesions are not expected to occur with a single series of treatments. Results are limited by many factors including the equipment capability as well as my personal skin characteristics. My Fitzpatrick Skin Typing has been analyzed and I understand that a higher Fitzpatrick Typing increases the potential risk of the treatment. Currently, “Pixel” Laser Skin Resurfacing and Intense Pulsed Light are limited to Fitzpatrick Skin Types I – IV. Hormonal therapy and other medical conditions may affect my results. Results are cumulative and a series of treatments as well as a well planned program of skin care products are necessary to achieve maximum benefit. Actual results cannot be guaranteed. My Fitzpatrick Skin Type is _____. ____Initials Side Effects and Complications Procedural Discomfort “Pixel” Laser Skin Resurfacing Pain and discomfort during the actual procedure of “Pixel” Resurfacing is minimal and many comment only that they feel a slight snap or electrical tingle with each Laser Pulse. At the end of the procedure the skin will start to feel slightly like a sun burn. At this time cold wash cloths and air will be blown on the face which relieves this to some extent. We will place some Javani Gel and other Hydrators such as B-5 Hydration Gel Prior to your departure. We may also use a light coat of a 1% Hydrocortisone Cream. ____Initials Intense Pulsed Light Pain and discomfort during the procedure are the most common described side effects. The pain is similar to a rubber band snapping against the skin and most individuals are able to tolerate this sensation for the short duration of the treatment. Dr. Christian may apply a topical anesthetic prior to the procedure in some individuals. I cannot have a topical anesthetic if I have a known allergy to “caine” type anesthetics such as benzocain, tetracain, xylocaine or lidocaine. Serious skin reactions and rarely death due to a severe allergy can occur ____Initials Infrared Skin Tightening During this procedure the Infrared Device is gently brushed across a small area of skin. After about 30 seconds the client will begin to feel some discomfort as the skin heats up. We will ask you to gauge your pain on a scale of 1-5 with 5 being very painful and not tolerable. When the skin gets to a 4 or 4.5 level, the client will indicate Page 6 of 10 by saying “Now” and Dr. Christian will remove the device for a few seconds and allow the skin to cool down and then start the process again. We want to heat up the skin to about a 4 level and keep it there for about 30 seconds. ____Initials Burning, Blistering, Scarring, Swelling and Infection The “Pixel” Laser, Intense Pulsed Light and Infrared Skin Tightening work by creating heat to damage the target lesion and hopefully leave the normal tissues undamaged. Sometimes the target lesions take up enough light and covert it to heat that swelling or burning and then a blister will form. For this reason, the initial treatment may be on the Conservative side to evaluate how your skin will respond. If Dr. Christian senses that my skin has been recently tanned, he has the option of canceling a scheduled procedure for 3 weeks until the tan has subsided. Please realize that a sunburn type sensation with a little swelling is normally seen for up to 2 days after these treatments especially in aggressively treated areas and around the eyes. This can be relieved to some extent with a 1% Hydrocortisone Steroid Cream and Lanacaine Topical Cream, both available over the counter. If blistering develops, I will contact Dr. Christian and he will prescribe a treatment program to allow for healing of the blister which may include antibiotics especially if there is a suspicion of infection or that the infection has spread to the blood (Very Rare). If untreated the blister may become infected with poor healing or pigment changes. Scarring is rare but can occur in individuals with a history of Keloid formation or if a secondary infection occurs. In some patients there can be activation of herpes simplex (cold sores) or herpes zoster (Shingles) in and around treated areas and I may need antiviral treatment to hasten resolution. ____Initials Bruising and Bleeding The “Pixel” Laser and Intense Pulsed Light can potentially can damage tiny blood vessels in the upper dermis. This might lead to the appearance of some bruising in the treated areas. Blood vessels however are not the target for the “Pixel” Laser but the Intense Pulsed Light is helpful for small red and blue spider like vessels of the cheek, nose and chin. A small bruise on the face will resolve in 7-10 days but on the body may take 2-4 weeks or longer to resolve. ____Initials Pigment Changes If a blister forms or some bruising occurs, the healing process may result in either some increased pigmentation or decreased pigmentation. This may last several months and slowly improve or may be permanent. The use of post treatment sunscreen can minimize this risk and in some cases bleaching creams may be of additional benefit. ____Initials Blindness or Eye Damage The “Pixel” Laser, without protective eyewear, may cause visual loss including blindness. It is important to keep eye shields on at all times during the procedure and I should keep my eyes closed in order to protect my eyes from accidental exposure. ____Initials . Page 7 of 10 Diamond Microdermabrasion or Facials with Javani We will perform 3 Diamond Microdermabrasions with the Javani Procedure in conjunction with these procedures to help hasten the removal of the damaged epidermal layer and pigmented lesions which are shedding. The side effects of these procedures consist only of some mild redness and a slight sunburned or wind burned feeling for about 12-24 hours after the procedure. Rarely some bruising or serious irritation may occur. ____Initials Operator Your procedure for the “Pixel” Laser, Intense Pulsed Light and the Infrared Skin Tightening will be provided by Dr. Christian who has been trained in laser science, use of the equipment, laser safety and skin care. ____Initials Safety All standard safety precautions will be followed to ensure the utmost safety during your treatments. This includes the use of protective eyewear at all times while the equipment is in use. We recommend removal of contact lenses during facial treatments. ____Initials Long Term Risk I understand that the long term risks of the “Pixel” Laser for Skin Resurfacing, Intense Pulsed Light and Infrared Skin Tightening may not be fully known. Although considered safe and research studies have shown these types of treatment to be useful for the Indicated conditions, Inside Outside Wellness Center and Medical Spa cannot be held responsible for any “Pixel” Laser Skin Resurfacing, Intense Pulsed Light or Infrared Skin Tightening risk not yet discovered or commonly known. ____Initials Continued Consent I agree that this consent shall apply to all subsequent treatments of a similar nature. ____Initials Guarantee I understand that although every reasonable effort will be made to achieve a desirable outcome no guarantees are stated or implied. If you incur a complication which prohibits further treatments we will refund your money. ____Initials Photographs I consent to the taking of photographs prior to and during the period of treatment to document the changes and any complications that might occur. These photographs will be the property of Dr. Christian and may be used for teaching and demonstration purposes and my identity will not be revealed at any time. ____Initials Page 8 of 10 Physician Option to Modify or Discontinue Program Dr. Christian reserves the option to modify the program at any time to achieve the best results with the technology we have available. In addition, Dr. Christian reserves the option to discontinue the program at any time he feels the patient is not complying with the directed skin care program or is having other procedures done at another facility which may jeopardize this program. I agree to inform Dr. Christian of new medicines or any new procedures I am having performed on my skin. ____Initials Post Procedure Considerations: Important Information Sun Exposure: I realize that exposing the treated area to the sun during the period of treatment will potentially reverse some of the beneficial changes we have achieved and may increase the risk of complications. Immediately after the procedure and for a few days the skin will have a mild to moderate sun burn feeling. Sun Exposure during this period would make it worse and should be avoided. I will not intentionally tan the treated areas and I will always use the recommended sun protection (SkinCeutical Daily Sun Defense SPF 20) if I go out in the sun, even on overcast and rainy days. UVA radiation will penetrate clouds and windows so protection is needed at all times. ____Initials Care of Treated Skin Post Procedure: 1. The “Pixel” appearance of the treated skin will be visible until the layer of dead epidermal skin sheds off and pigmented lesions will be slightly darker. On about the 3rd day the dead epidermal layer will feel a little “leather” like and then start to slowly shed. Pigmented lesions should flake off by the 7th day. 2. I will clean my skin twice daily with a gentle cleanser and not attempt to pick at or peel off the dead epidermal layer or the pigmented lesions which are shedding. I will let this layer of dead skin and the pigmented lesions come off naturally. I realize that removing this shedding layer or the flaking pigmented lesions prematurely may lead to an underpigmented area which may be much different from the surrounding skin, especially if my skin has some natural pigment in it. 3. The ‘Pixel” appearance may be concealed to some extent with make up or foundation but in some cases it actually makes the “Pixel” appearance more exaggerated. Simply keeping the skin hydrated with Javani Cream, B-5 Hydrating gel or applying the 1% Hydrocortisone Cream will tend to minimize the “Pixel” appearance. ____Initials Blistering: If a blister develops, I will notify Dr. Christian for instructions on how to care for it. ____Initials Page 9 of 10 Followup Visits: I understand Dr. Christian may ask me to return for a short visit 1-3 days after my procedures to check on my skin and the results of the procedure. These visits are important as they give Dr. Christian a better idea of the settings to use at my next session. If Dr. Christian asks me to return for a short followup visit I will do so and not make him chase me down. ____Initials I certify that I am a competent adult of at least 18 years of age. Minors (under 18 years of age) require additional consent form a parent or legal guardian. ____Initials Importance of On Time Appointments I will do my best to be on time for the appointments. There is much to do in the hour allotted for the treatments. I realize that it is not safe to have Dr. Christian rushed through a “Pixel” Laser treatment. If you are over 15 minutes late we may decide to reschedule the procedure. ____Initials My signature attests to the fact that I have fully read this entire Consent and Disclosure form, that I have had any concerns answered to my satisfaction, that I understand the information contained within, and accept the risks inherent in “Pixel” Laser Skin Resurfacing and/or Infrared Skin Tightening Treatments. I hereby consent to proceed with the ‘Mini” Non-Invasive Extreme Makeover consisting of 3 Diamond Microdermabrasions with Javani Procedure, “Pixel” Laser Skin Resurfacing, Intense Pulsed Light and Infrared Skin Tightening Treatments. In understand the areas to be treated are the Face for the Intense Pulsed Light, ‘Pixel” Laser and Diamond Microdermabrasions. The Neck, Cheek and Jowls will be treated with Infrared Skin Tightening. If I desire other areas to be treated there will be an additional charge. Please Initial other Area(s) to be treated. Neck “IPL”: _________ Neck “Pixel”: __________ Hands “IPL”: _________ Hands “Pixel”: __________ Chest “IPL”: _________ Chest “Pixel”: ________ Other, Identify: _______________________ Date: _______________ Signed: ___________________________ Printed Name: _________________________ Parent/Legal Guardian for Patient under 18: _____________________________ Page 10 of 10