THIS INFORMED CONSENT FOR TRETINOIN (THE “CONSENT”) SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE “MEDICAL GROUPS”) THROUGH THE ONLINE TECHNOLOGY PLATFORM (“PLATFORM” OR “SUPERPOWER PLATFORM”), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. (“SUPERPOWER”).
This informed consent is for the use of topical tretinoin, a prescription medication, for the treatment of acne, fine wrinkles, and rough skin. The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with tretinoin treatment in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by your Medical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.
Tretinoin is a derivative of vitamin A that falls under the class of medications known as retinoids. It is commonly used in dermatology for its efficacy in treating a variety of skin conditions, primarily acne vulgaris and photoaging. Tretinoin works by promoting skin cell turnover, which helps to clear pores, reduce inflammation, and improve the appearance of the skin. Tretinoin is FDA approved for topical application for treatment of acne vulgaris in addition to adjunctive palliative treatment of photoaging including: fine facial wrinkles, facial skin roughness, and facial mottled hyperpigmentation.
While tretinoin can significantly improve skin conditions, it may also cause side effects, especially during the initial weeks of treatment. During the initial weeks of treatments common side effects include:
Dryness, Redness, Exfoliation/Peeling, Itching, Sensitive Skin, Burning sensation on the skin, Wrinkles may look worse and Acne may look worse. The adverse effects do tend to improve over time after a peak after about two weeks of daily use. And you can minimize the irritation by starting at a lower concentration (for example .025 percent instead of 0.1 percent) and slowly ramping up from applying at first twice a week for a few weeks, then to every other night for a few more weeks, before finally advancing to nightly application as tolerated.
More specifically, common side effects include, but are not limited to:
Serious side effects are rare but may include:
It’s important you understand that the risks of long-term use are unknown. A recent trial ”Topical Tretinoin Therapy and All-Cause Mortality: The Veterans Affairs Topical Tretinoin Chemoprevention” was to be a six-year randomized controlled trial to see if topical tretinoin could help prevent skin cancer. But the trial had to be stopped early, because significantly more people were dying in the retinoic acid group than in the placebo-cream group. At the time the study was halted, 19 percent of the subjects in the tretinoin group had died, compared to 14 percent in the placebo group. Between 1 to 8 percent of topically applied retinoic acid is absorbed into the bloodstream. We don’t know if the increase in deaths was a statistical fluke that happened by chance, or a real biological effect. The probability that we’d see such a discrepancy just by chance is about 1 in 100. Tretinoin continues to be banned in Europe for cosmetic purposes.
Tretinoin is contraindicated in the following situations:
If any of these contraindications apply to you, inform your clinician before starting treatment.
Your Healthcare Provider will determine the appropriate formulation and concentration of tretinoin based on your skin type, acne severity, skin aging, and history of retinoid use. Apply the medication as directed by your Healthcare Provider, typically to clean, dry skin, avoiding sensitive areas around the eyes, mouth, and angles of the nose. Expect an initial worsening of acne and skin irritation during the first few weeks of treatment, with improvements typically observed after 8 to 12 weeks of consistent use. Best results are achieved with adherence to the program over several weeks and/or months. Use a non-comedogenic moisturizer as needed to minimize dryness and irritation. Avoid using products containing alcohol, menthol, or astringents that may exacerbate these effects.
You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:
Possible Risks of Telehealth
There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:
Due to state licensure requirements for healthcare providers, you must be physically located in the state that your Healthcare Provider is licensed in during your telehealth visit.
By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.
PLEASE NOTE: THE MEDICAL GROUPS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, ARE CONSIDERING HARMING YOURSELF OR OTHERS, OR ARE OTHERWISE IN IMMINENT DANGER, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM.
You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Healthcare Provider(s) via the Superpower Platform.
All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use the Clinical Services at any time, seek treatment elsewhere and/or with in-person offerings.
Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with topical tretinoin therapy with a Medical Group Healthcare Provider via the Superpower Platform:
BY SIGNING THIS INFORMED CONSENT, YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT TRETINOIN TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS. YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TO YOUR HEALTHCARE PROVIDER PROMPTLY.
Use the tretinoin exactly as directed and written on your prescription label and directed by your Healthcare Provider. Do not use more of it, do not use it more often, and do not use it for a longer time than your Healthcare Provider ordered. By FDA law, this medication is not for resale nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals. Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.You understand that the Healthcare Provider prescribing tretinoin holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.
You acknowledge that there are no guarantees or assurances made with respect to the results of using the tretinoin prescribed for you, and there are no guarantees that there will not be side effects and complications.
You understand that tretinoin may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing Healthcare Provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with tretinoin, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers or Superpower if you fail to do so.
BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE TRETINOIN TREATMENT THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF A MINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.
MEMBER NAME: ___________________________
SIGNATURE: _____________________________
DATE: __________________________________
