Information and Consent for Obagi Medical Products

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Important Background to the Consent Process

Your clinician wishes to help you make an informed decision about your treatment options and any relevant alternative options. You may at any time decline treatment even after giving your consent.

Whilst your clinician will make every effort to understand what significance you would attach to any particular risk it is important to us that you feel comfortable enough to question the clinician on any point of concern during this process. Please feel you have as much time as you wish to reflect on the information given before agreeing to proceed with the treatment.

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Purpose of Treatment

You have presented with concerns which have formed the basis of a clinical discussion and examination. The purpose of the proposed treatment is to address your concerns either individually or in combination with other modalities of treatment.

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Outcomes

Your clinician will endeavour in good faith to employ the principles of best practice in delivering your treatment. Each patient is individual and response to treatment will vary from patient to patient and treatment to treatment. As such it is difficult to guarantee outcomes will always meet your expectations.

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Background Information

Obagi Medical is a global speciality pharmaceutical company founded by leading skin care experts in 1988. Obagi products are designed to help minimize the appearance of premature skin aging, skin damage, hyperpigmentation, acne and sun damage, and are primarily available through dermatologists, plastic surgeon, medical spas, and other skincare professionals.

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Commonly Experienced Adverse Events

• Redness Dryness/Flakiness/Peeling Skin sensitivity
• Breakouts of spots
• Tight feeling of the skin
• Less Common Risks
• Allergic reactions
• Hyperpigmentation/ hypopigmentation Infection

Important Considerations

Every care is taken to deliver the treatment in a manner which will minimise risk, however you should be aware of the risks, as one may exist upon which you place particular significance.

Patients are advised to take in to account all these potential risks before consenting to treatment. Please make your clinician fully aware of your expectations prior to giving consent.

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Safety Profile

Although there is a proven record of safety with Obagi products, some people may be sensitive to certain ingredients which will require patch testing prior to use.

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Contraindications and Relative Contraindications to Treatment

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• Recent natural or artificial exposure to UV light resulting in a burn Eczema
• If you are pregnant or breast feeding
• Active skin infections
• Specific conditions as outlined by your consultant relevant to the products you will be using
• Allergies to any ingredients within products (a test patch may be required in certain circumstances prior to treatment)
• History of Herpes Simplex Virus infection (cold sores)

Limited or no clinical data exists regarding the efficacy and tolerance of these products in patients having a history of, or currently suffering from, auto-immune disease or auto-immune deficiency or being under immunosuppressive therapy.

The clinician shall therefore decide on the indication on a case by case basis according to the nature of the disease and its treatment and the need for monitoring. Your clinician will discuss the need for a preliminary skin testing for hypersensitivity if necessary, or in the case of patients with severe or multiple allergies.

Your clinician will also discuss the suitability of the product(s) having considered your medical history and any medications you currently take, as appropriate. As such, it is imperative you disclose such medications during your consultation.

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For patients receiving Tretinoin therapy, please be aware of the following information

Therapy with tretinoin may make your skin more susceptible to sunburn and other adverse effects of the sun, so unprotected exposure to natural or artificial sunlight should be minimized. When outside, even on hazy days, areas treated with tretinoin should be protected. An effective sunscreen should be used any time you are outside (consult your physician for a recommendation of an SPF level which will provide you with the necessary level of protection). For extended sun exposure, protective clothing, like a hat, should be worn. Do not use artificial sunlamps while you are using tretinoin. If you do become sunburned, stop your therapy with tretinoin until your skin has recovered.

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Extremes of climate tend to dry or burn normal skin. Skin treated with tretinoin may be more vulnerable to these extremes. Your physician can recommend ways to manage your acne treatment under such conditions.

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Rare Risks

The skin of certain sensitive individuals may become excessively red, swollen, blistered or crusted. If you are experiencing severe or persistent irritation, discontinue the use of tretinoin and consult your physician.

There have been reports that, in some patients, areas treated with tretinoin developed a temporary increase or decrease in the amount of skin pigment (colour) present. The pigment in these areas returned to normal either when the skin was allowed to adjust to tretinoin, or therapy was discontinued.

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Additional Information

Do not use other medications with tretinoin which are not recommended by your doctor. The medications you have used in the past might cause unnecessary redness or peeling.

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What to expect with your new treatment

Tretinoin works deep inside your skin and this takes time. You cannot make tretinoin work any faster by applying more than one dose each day, but an excess amount of tretinoin may irritate your skin. Be patient.

There may be some discomfort or peeling during the early days of treatment. Some patients also notice that their skin begins to take on a blush

These reactions do not happen to everyone. If they do, it is just your skin adjusting to tretinoin and this usually subsides within two to four weeks.

These reactions can usually be minimized by following instructions carefully. Should the effects become excessively troublesome, consult your doctor.

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For patients receiving hydroquinone therapy, please be aware of the following information

Hydroquinone is used to reduce the pigmentation of the skin by inhibiting the production of melanin.

Treatment with hydroquinone is often well tolerated, but your sensitivity may be tested by applying a small amount to the skin and noting any redness or itching. If no reaction occurs, then your clinician will advise you to continue treatment. After application, it is important to wash your hands thoroughly to prevent any unwanted lightening of the skin.

Prolonged use of hydroquinone has the rare risk of causing ochronosis, a blue-black pigmentation with caviar-like papules on the skin.

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