INFORMED CONSENT FOR TREATMENT WITH BOTULINUM TOXIN

Botulinum toxin has been used for many years in neurological, physiatric, maxillofacial, and ophthalmological fields, particularly for the treatment of spasmodic torticollis, spastic tetraparesis, strabismus, blepharospasm, and other conditions.
Its use is currently also permitted in the field of aesthetic medicine, limited to the area of ​​glabellar wrinkles (between the eyebrows) in adult patients under 65 years of age. The drug may be used to treat wrinkles in other anatomical areas of the face and in patients over 65 years of age only pursuant to Law 94/98, which constitutes "off-label" use. This use may only occur with the patient's consent, who declares that he or she has been fully informed and approves of this use, which involves the use of the drug for a therapeutic indication other than that specified in the Ministerial Decree for Marketing Authorization. This treatment is recommended to patients exclusively because there is internationally accredited scientific literature justifying its use and proving its therapeutic efficacy, and because there are no alternative treatments with equivalent efficacy using medications authorized for this therapeutic indication, considering their invasiveness, expected outcomes, etc.

Specifically, in the aesthetic medicine field, it can be indicated for facial wrinkles, neck areas, the "gummy smile," bruxism, and the treatment of palmar, plantar, and axillary hyperhidrosis (sweating). The action of botulinum toxin injected with a thin needle into the specifically affected muscles causes flaccid paralysis, usually reversible within 3-4 months, with the effect of relaxing the treated areas. In the case of hyperhidrosis, intradermal microinjections are performed that act on the sweat glands, inhibiting the effect of sweating.
The results are not immediate and usually consolidate after 4 to 15 days. After 2 to 5 months, the effect disappears and the treatment must be repeated to maintain the results. Rarely, the therapeutic effect is not evident; in this case, a touch-up is possible within about 15 days, after which the toxin should not be repeated for at least 4 months. An allergy test is not performed as it is not required; the procedures and tools used are those currently recognized as the most suitable from a medical-scientific perspective according to international scientific consensus.

The procedure may cause risks or complications for reasons unrelated to the physician's proper use. Therefore, precise guarantees cannot be given regarding the outcome of this treatment, particularly regarding its duration of effectiveness, as many factors can contribute to the premature deterioration of the drug's effect.
All pre- and post-treatment instructions provided by the physician must be followed scrupulously, as they are essential to achieving the desired outcome. It is necessary to disclose to the physician without reservations your current health status, any allergies or intolerances, any previous aesthetic or surgical treatments performed on the area to be treated with Botulinum Toxin or surrounding areas, as well as any previous Botulinum Toxin treatments, specifically indicating the product used and the time of injection, in order to allow the physician to evaluate any contraindications to the treatment.

Direct exposure to ultraviolet rays (sunlight, sunlamps), heat (very hot showers, saunas, and Turkish baths), or intense cold is absolutely not recommended for the four weeks following treatment. Avoid all traumatic procedures (rubbing the treated area, scrubs, brushing, aesthetic therapies, etc.), and the use of inappropriate cleansers or cosmetics, which may increase the risk of side effects and alter the intended therapeutic result.

It is also advisable to avoid significant amounts of alcohol and spirits for a period of 10-14 days.
As advised by your doctor, you should be aware of your skin's characteristics and the specific precautions you should take before and after treatment.
It is possible that treatments may need to be repeated to achieve the desired outcome.
For any prolonged or unusual side effects, as well as for concerns about the outcome, it is advisable to contact your doctor for a follow-up visit.

The procedure may cause risks or complications for reasons unrelated to the physician's proper use. Therefore, precise guarantees cannot be given regarding the outcome of this treatment, particularly regarding its duration of effectiveness, as many factors can contribute to the premature deterioration of the drug's effect.
All pre- and post-treatment instructions provided by the physician must be followed scrupulously, as they are essential to achieving the desired outcome. It is necessary to disclose to the physician without reservations your current health status, any allergies or intolerances, any previous aesthetic or surgical treatments performed on the area to be treated with Botulinum Toxin or surrounding areas, as well as any previous Botulinum Toxin treatments, specifically indicating the product used and the time of injection, in order to allow the physician to evaluate any contraindications to the treatment.

Direct exposure to ultraviolet rays (sunlight, sunlamps), heat (very hot showers, saunas, and Turkish baths), or intense cold is absolutely not recommended for the four weeks following treatment. Avoid all traumatic procedures (rubbing the treated area, scrubs, brushing, aesthetic therapies, etc.), and the use of inappropriate cleansers or cosmetics, which may increase the risk of side effects and alter the intended therapeutic result.

It is also advisable to avoid significant amounts of alcohol and spirits for a period of 10-14 days.
As advised by your doctor, you should be aware of your skin's characteristics and the specific precautions you should take before and after treatment.
It is possible that treatments may need to be repeated to achieve the desired outcome.
For any prolonged or unusual side effects, as well as for concerns about the outcome, it is advisable to contact your doctor for a follow-up visit.

The doctor has explained to you the alternative procedures that may be available, their advantages and disadvantages, risks, and benefits.
The quality of the clinical outcomes of the treatment cannot be assessed a priori, and precise guarantees regarding the results achievable with this treatment cannot be provided, as the individual response and conditions may be essential in determining the clinical response of the treated patient.

It is therefore important that the explanations summarized here, thoroughly illustrated by the doctor, are well understood and deemed comprehensive by the patient.

To this end, I DECLARE

That I have received from the doctor extensive, complete, and comprehensive explanations of the information summarized in this information, and that I have no other questions or doubts regarding the treatment covered by this consent form (a copy of which I may request), having therefore understood all the elements necessary to make a free and informed decision regarding the treatment.

In the doctor-patient relationship, it is necessary and ethically correct for the patient to assume a conscious and participatory role in the treatment and diagnostic tests they voluntarily undergo, as also required by Articles 33, 34, 35, 36, and 37 of the Code of Medical Ethics.
For this reason, the patient is informed in a comprehensible manner about their problem and/or pathology, is explained the possible treatments, and the rationale for choosing the one(s) deemed most suitable to achieve the desired clinical outcome is provided.

It is therefore important that the explanations summarized in the treatment information provided by the doctor, signed by you as a summary of the doctor's extensive description and explanation, are fully understood and deemed comprehensive by the patient.

To this end, I DECLARE

that I have been adequately informed about the treatment protocol, the related clinical situation and diagnosis, the therapeutic options, benefits, limitations, alternatives, possible side effects, and the indications and procedures I will need to follow pre- and post-treatment to achieve the desired outcome, in order to enable me to make a voluntary and consequently informed decision.

I CONFIRM

that I have fully understood and deemed the information provided by the doctor regarding the Botulinum Toxin A treatment I have decided to undergo to be comprehensive. Specifically, I acknowledge that I have been informed of my clinical situation and the related diagnosis, the therapeutic options, benefits, limitations, alternatives, possible side effects, complications, and outcomes, pre- and post-treatment indications and procedures, as well as the frequency and repetitiveness of the treatment. I am aware of the importance of disclosing without reservations my health status, any allergies, sensitivities to excipients, medications recently or currently taken, as well as any previous therapies or medical or other treatments performed on the muscle area and in the areas adjacent to the treatment area.

I have been informed of possible alternative procedures, their advantages and disadvantages, risks, and benefits, and I am confident that I have fully understood them and will opt for this treatment.
I am aware that the quality of the results cannot be assessed a priori, and that I have not been given precise guarantees regarding the results I will achieve with this treatment, as individual response and conditions may be essential in determining the outcome.

Having read the above, I believe I have correctly understood it and received the requested clarifications.

Clinica Milano – Skin Lab ®. to carry out medical treatment using BOTULINUM TOXIN TYPE A with the medicinal specialty authorized in Italy:

In the event of OFF-LABEL use, I confirm that I have fully understood what the doctor explained to me during the preliminary consultation regarding the assumption of doctor-patient responsibility, the available clinical literature, the aspects relating to therapeutic alternatives and current legislation, as well as the risks, indications, and contraindications of the specific application, including any notes listed above.

I declare that I have disclosed my health status without reservations, in order to allow the doctor to evaluate any contraindications.

Pursuant to Articles 13 and 14 of EU Regulation No. 2016/679 (the "Regulation") and the provisions of Legislative Decree No. 101/18 (the "Legislative Decree") concerning the protection of natural persons with regard to the processing of personal data, I hereby inform you that the personal data you provide and acquired by Clinica Milano – Skin Lab ® will be processed in compliance with the provisions of the aforementioned Regulation and Legislative Decree. Furthermore, the following is specified:

1. Purpose of processing

The processing of your personal data is solely for the proper performance of aesthetic medicine, prevention, diagnosis, treatment, rehabilitation, or other pharmaceutical and/or specialist services requested by you.

2. Methods of Processing Personal Data

Processing is carried out through operations performed on paper or with the aid of IT tools, or via apps and cloud platforms, and consists of the collection, recording, organization, storage, consultation, processing, modification, selection, extraction, comparison, use, interconnection, blocking, communication, deletion, and destruction of such data. Sometimes, it may be necessary to send data electronically via email, which will be encrypted and password-protected. Processing is carried out by the data controller and by persons expressly authorized by the data controller.

3. Provision of Data and Refusal

The provision of general, sensitive, genetic, and health-related personal data is necessary for the performance of the activities required for prevention, diagnosis, treatment, rehabilitation, or other pharmaceutical and/or specialist services requested by you. Your refusal to provide personal data will make it impossible to perform these activities.

4. Data Disclosure

The personal data collected will not be disclosed. The data will not be shared with third parties, except when necessary and/or required by law and/or for tax compliance. The data will be disclosed only to healthcare personnel at the facility where Clinica Milano – Skin Lab® operates and, where necessary, to physicians, analysis laboratories, medical specialists, hospitals, and consultants—lawyers and/or accountants—used by Clinica Milano – Skin Lab®.


5. Data Retention

Your personal data will be retained for the time strictly necessary for medical care and, in any case, for no longer than ten years. Even when computers are used, appropriate protection measures are adopted to ensure the correct storage and use of data, including by medical practice staff, in compliance with professional secrecy. Professionals and facilities that may have access to such data as a result of the healthcare services provided by Clinica Milano – Skin Lab ® are also required to observe these safeguards.

6. Data Controller

The data controller is Clinica Milano – Skin Lab ®, Via Cerva, 22 – 20122 Milan – SEM s.r.l. | VAT No. 11055590969

7. Rights of the Data Subject

The data subject has the right:

• to request from the data controller access to, rectification or erasure of, or restriction of processing of, personal data, or to object to processing, as well as the right to data portability;
• to receive, in a structured, commonly used, and machine-readable format, the personal data concerning him or her, which he or she has provided to a data controller, and has the right to transmit those data to another data controller without hindrance from the data controller to which the personal data have been provided;
• to withdraw consent at any time, without affecting the lawfulness of processing based on consent before its withdrawal;
• to lodge a complaint with the Italian Data Protection Authority.

The aforementioned rights may be exercised by written communication sent via certified email to semsrl1@pec.it or by registered mail with return receipt to Via Cerva, 22 – 20122 Milan.

With reference to the images (photos and/or videos) taken and/or filmed by Clinica Milano – Skin Lab ®, which are essential for developing your treatment plan and managing diagnoses and future assessments, you authorize, free of charge and without time limits, also pursuant to Article 10 of the Italian Civil Code and Articles 96 and 97 of Law No. 633 of April 22, 1941 (Copyright Law), the storage in your medical records in paper format or with the aid of IT tools or via apps and platforms that use the Cloud, and the possible publication and/or dissemination of your images in any form on the Clinica Milano – Skin Lab ® website or on its social media profiles such as Instagram or Facebook. I also authorize the storage of these photos and videos in the electronic archives of Clinica Milano – Skin Lab®, confirming that the purpose of such publications is purely for informational and educational purposes regarding the professional activities carried out by Clinica Milano – Skin Lab®. This authorization may be revoked at any time by written notice sent by registered mail or certified email.

The undersigned declares that he or she has read the above information, accepts all of its provisions, and consents to the processing of his or her personal data for the purposes, terms, and conditions set forth above.