Sculptra

This material is provided to Beverly Hills Rejuvenation Center for Franchisees’ use in training their employees. Franchisees may use the material and modify it as they wish so long as they are able to deliver services to meet brand standards. Franchisees are required to align these instructions with current federal, state, and local regulations related to aesthetics practices.

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STANDARDIZED PROCEDURE AND PROTOCOL FOR:

SCULPTRA® Aesthetic

To ensure safe and effective treatment of clients undergoing Injectable SCULPTRA® Aesthetic administration at BeverlyHills Rejuvenation Center LOCATION NAME, the following policies and procedures have been developed.

SCULPTRA® Aesthetic is an injectable implant containing micro-particles of poly-L-lactic acid(PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP). 

Policy:

A Physician, NursePractitioner (PA), Physician Assistant (PA) or Registered Nurse (RN), with current state licensure, herein referred to as AUTHORIZED LICENSED MEDICAL PERSONNEL, shall be able to assess, consult, and treat clients with Injectable Fillers following the guidelines set forth herein.

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Setting:

The AUTHORIZED LICENSED MEDICAL PERSONNEL can perform the administration of SCULPTRA® Aesthetic injections in various settings and locations, such as but not limited to:

• Physician Office
• Satellite Clinic / Health Care Office(s)
• Medical Spa Setting medically zoned and authorized by the Medical Director
  ADDRESS

 All injectable Sculptra administration shall be performed in a clean, safe environment, equipped with proper sharps disposal system, and have universal precautions in place. The Physician, Nurse Practitioner, or Physician Assistant must perform the “Good Faith Exam” prior to each client receiving a dermal filler injection before the procedure may be performed by the Registered Nurse (RN).

Supervision:

The AUTHORIZED LICENSED MEDICAL PERSONNEL shall function under the general supervision of the Medical Director, who is available for consultation by phone or email and is available as medically necessary. The level of supervision will be as required by state laws and regulations.

Side effects may appear either at the time of treatment or shortly thereafter. Adverse reaction(s) shall be documented in the client’s treatment record. All adverse reactions such as bruising, asymmetry, corrections, lumpiness, injection site pain, nodules, nasopharyngitis, headache, injection site erythema, excessive swelling shall be reported immediately to the Medical Director. Adverse reaction(s) shall be documented in the client’s chart.

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Patient Conditions:

The AUTHORIZED LICENSED MEDICAL PERSONNEL will not knowingly treat any clients with Sculptra / Poly-L-Lactic acid products that are known to have/be:

1. Hypersensitivity to any of the components of SCULPTRA Aesthetic (see DEVICE DESCRIPTION).
2. A known history of or susceptibility to keloid formation or hypertrophic scarring.
3. Pregnant or breastfeeding.
4. Presence of infection or any other inflammatory condition at the proposed treatment site.

The AUTHORIZED LICENSED MEDICAL PERSONNEL will only treat patients with Injectable Sculptra after successfully completing a comprehensive clinical training program. The AUTHORIZED LICENSED MEDICAL PERSONNEL will not treat any areas that were not specifically taught in their training program.

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Basic Poly-L-Lactic acidInjection Guidelines:

Poly-L-LacticAcid: Is a biocompatible, biodegradable synthetic substance. Poly-L-Lactic acid fillers are considered “semi-permanent,” as the results typically last more than 2 years, and can help stimulate collage production. It differs from the other fillers as it stimulates the body to create its own natural collagen to create volume. FDA-approved Poly-L-Lactic acid fillers include:

• Sculptra

The following supplies are used with SCULPTRA Aesthetic:

• SterileWater for Injection (SWFI), USP
• Single-use 5mL sterile syringe
• Single-use 1or 3 mL (depending on physician practitioner preference) sterile syringes (at least 2)
• 18 G gauge sterile needles (at least 2)
• 26 Gauge sterile needles (several should be available); do not inject with any needle smaller than 26G diameter or bent needles.
• 25 gauge1 ½ inch sterile needles (several should be available)
• 22 gauge2inch or 2.5 inch Cannula
• Antiseptic(such as alcohol and/or chlorhexidine)

Reconstitution

SCULPTRA® Aesthetic is reconstituted in the following way:

1. Remove the flip-off cap from the vial and clean the penetrable stopper of the vial with an antiseptic. If the vial, seal, or flip-off cap is damaged, do not use, and call Sanofi-Aventis U.S. LLC at 1-800-633-1610.
2. Attach an 18G sterile needle to a sterile single-use 10 mL syringe.
3. Draw 8 mLs of Sterile Water into the 10 mL syringe.
4. Introduce the 18 G sterile needle into the stopper of the vial and slowly add all SterileWater into the vial.
5. Let the vial stand for at least 2 hours to ensure complete hydration; do not shake during this period. SCULPTRA Aesthetic can be stored at room temperature up to 30°C(86°F) during and after hydration. Refrigeration is not required.
6. Productshould be gently agitated immediately prior to use. Agitate the vial until auniform translucent suspension is obtained. A single vial swirling agitator maybe used. The reconstituted product is usable within 72 hours of reconstitution.As it is a single use vial, discard any material remaining after use or after72 hours following reconstitution.
7. SCULPTRA® PREPARATION RECONSTITUTION:
8. SCULPTRAFACE: 8cc of sterile water 72 hours prior to injection.  Day of injection reconstitute with anadditional 1cc of Lidocaine 1%. Totaldilution equals 9cc.
9. SCULPTRABUM, CHEST, THIGHS (cellulite), and KNEES (laxity): 8cc of sterile water 72hours prior to injection. Day of injection reconstitute with an additional 1ccof Lidocaine 1%, AND another 9cc ofsterile water OR 9cc ofbacteriostatic normal saline. Totaldilution equals 18cc.
10. Clean thepenetrable stopper of the vial with an antiseptic, and use a new 18 G sterileneedle to withdraw an appropriate amount of the suspension into a single–use 3mL sterile syringe. Do not store the reconstituted product in the syringe.
11. Replace the18 G needle with a 26 G sterile needle or 22 guage cannula before injecting theproduct into the deep dermis. Do not inject SCULPTRA Aesthetic using needles ofan internal diameter smaller than 26 G, or bent needles.
12. To withdraw remaining contents of the vial,repeat steps 6 through 8.

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Injectable Fillers Treatment Procedure:

The AUTHORIZEDLICENSED MEDICAL PERSONNEL will be very familiar with the officialdermal filler package insert from the manufacturer of SCULPTRA®and will:

1.    Counsel Patient

It is necessary to counsel the patient and discuss the appropriateindication, risks, benefits and expected responses to the SCULPTRA® Aesthetic treatment. Advise the patient ofthe necessary precautions before commencing the procedure.

o  Beforetreatment with SCULPTRA® Aesthetic,a patient should be provided patient labeling and completely informed by thetreating provider of the intended use, indications for use, as well as thecontraindications, warnings and precautions for use, expected correction, andpossible side effects and mode of administration of SCULPTRA Aesthetic. Eachpatient should be informed that

the amount of SCULPTRA® Aestheticand the number of injection sessions will depend on the patient's need.

o  A treatmentsession to correct WAS 2 – 4 contour deficiencies (see picture, Figure 2 ) of facial wrinkles such as nasolabial foldsconsist of multiple deep dermal threading or tunneling injection of 0.1–0.2 mLof SCULPTRA® Aesthetic in grid pattern to a maximum of2.5 mL per nasolabial fold per session.

Figure 2

1.    One to fourtreatment sessions (typically three) might be needed to achieve optimalcorrection with a minimum of three-week intervals between injection sessions.

2.    Patientsshould be informed that typically, at the end of the injection session, theywill experience some degree of swelling due to the water (SWFI) used toreconstitute SCULPTRA Aesthetic and this will give the appearance of a fullcorrection by the end of the injection session.

3.    Patientsshould be informed that the injection-related swelling typically resolves inseveral hours to a few days, resulting in the reappearance of the originalcontour deficiency.

4.    Patientsshould also be informed that the optimal correction after initial injectiondepends on patient's pre-treatment nasolabial fold WAS score. In the clinicalstudy, optimal correction at 9 weeks after initial injection was most commonlyfound to be a 0.5 to 1-point decrease in WAS.

5.    Patientsshould be informed that, if needed, their physician may utilize a topical or alocal anesthetic prior to injecting SCULPTRA® Aesthetic.

2. Conduct Patient Assessment

1.     A complete medical history should be taken todetermine if SCULPTRA® Aesthetic injectionis appropriate. Using the standard wrinkle assessment score (WAS) photographsprovided for patient counseling, a patient should be informed of the optimalcosmetic correction that may be expected by that patient, and that up to fourinjection sessions (typically three) may be needed to achieve the desiredresults.

2.     During the initial treatment session with SCULPTRA® Aesthetic, only a limited correction shouldbe made. In contrast to other wrinkle fillers, SCULPTRA® Aesthetic provides a gradual improvement of the depressed area overseveral weeks as the treatment effects occur.

3.     Prepare Patient

o   Each injection session is to be conductedwith aseptic technique and universal precautions due to the potential forcontact with patient body fluids: blood from the injection site. Beforeinjecting SCULPTRA® Aesthetic atreatment plan is determined and the face mapped. The mapping is done using awater soluble pencil and a grid that is parallel and perpendicular to thenasolabial fold is outlined. See Section6 - Injecting: Threading or Tunneling Technique.

o   Picturesare taken before each treatment and uploaded into the patient's EMR chart.

o  Oncethe area to be treated is defined and an appropriate examination is completed,the patient is seated. If topical anesthetic is to be used, it is appliedliberally to the treatment areas and should be allowed to work for at least 15minutes prior to injection.

o  Theadhesive patient record label from the packaging should be removed and placedin the appropriate location on the treatment record in the patient’s chart, ortransferred to the electronic record (keep consistent with clinical charting).

o  Thetreatment area should be prepped by cleansing and removing the topicalanesthetic and/or makeup with alcohol or chlorhexidine or another antiseptic.

4.     Injection Needle

o   SCULPTRA® Aesthetic should be injected using a sterile26 G needle. SCULPTRA® Aestheticshould not be injected with needles with a diameter smaller than 26 G orneedles that have been bent. To maintain a uniform suspension throughout theprocedure, intermittently agitate SCULPTRA® Aesthetic in the syringe. Before initial injection, expel a few dropsof SCULPTRA® Aesthetic through the attached 26 G needleto eliminate air and to check for needle blockage. If the needle becomesoccluded or dull during an injection session needle replacement is necessary.If clogging occurs, remove the needle, expel a small amount of product, attacha new sterile 26g needle, then expel a few drops of SCULPTRA® Aesthetic to eliminate the air and re-checkfor needle blockage.

5.     Depth of Injections

o   SCULPTRA® Aesthetic should be injected into the deepdermis with tunneling (threading) technique.

As per Figure 7, SCULPTRA® Aestheticshould be injected into tissue that is medial to the nasolabial fold wrinkledefect.

To guide the needle to the deep dermal plane, create a firm needleinsertion plane by stretching the skin (Figure 3).

Figure 3

Introduce a straight, sterile, bevel-up 26 G needle into the skin at anapproximately 30–40 degree angle to the skin and then advance the needle to thedeep dermis until the desired skin depth is reached (Figure 4).

Figure 4

A change in tissue resistance is felt when the needle crosses from thedermis into subcutaneous layer. If the needle is inserted at too shallow(small) an angle or if the needle tip is not sufficiently advanced, then theneedle tip may be in the mid or superficial (papillary) dermis, the needlebevel may be visible through the skin. If SCULPTRA® Aesthetic is injected too superficially, the injected area will blanchimmediately or slightly after injection. If the injected area blanches, removethe needle and massage the area in a circular fashion. In the event that theblanching does not disappear, the patient should not be re-injected.

6. Injecting: Threading or TunnelingTechnique in a Grid Pattern (cross-hatch).

a.Technique.
When the needle tip is in the deep dermal plane, the needle angle should belowered to 10–20 degrees and the needle should be advanced in the deep dermalplane parallel to the surface of the skin (Figure 5).

Figure 5

Before injecting SCULPTRA® Aesthetic,always perform a reflux maneuver to avoid intravascular injection. If bloodreturns to the syringe, the needle is in a blood vessel and should bewithdrawn, pressure should be applied to the injected area until bleeding stopsand a new syringe should be prepared. If no blood is pulled back into thesyringe, use the threading or tunneling technique, to deposit a thin trail of SCULPTRA® Aesthetic by doing a retrograde injectionwhen slowly withdrawing the needle (Figure 6).

Figure 6

Based on the treatment plan (see Section3 - Patient Preparation), Start the first injection at the base of the nasolabial fold. Aftercompleting the length with injections parallel to the nasolabial fold, thecross-hatch pattern is achieved with additional injections perpendicular to thefirst injection. Picture below shows a cross-hatch pattern after completing thelast injection (Figure 7).

Figure 7

b.Volume Per Treatment Injection

The maximum volume of SCULPTRA® Aestheticper individual injection should be limited to 0.1 mL – 0.2 mL, spaced at adistance of 0.5 –1 cm. Avoid overcorrection.

c. Volume Per Treatment Site

A treatment session to correct WAS 2 – 4 nasolabial fold contourdeficiencies consists of multiple deep dermal threading or tunneling injectionof 0.1–0.2 mL of SCULPTRA Aesthetic in grid pattern to a maximum of 2.5 mL pernasolabial fold per session. The volume of SCULPTRA® Aesthetic per surface area of injection grid has not been determined.During the initial treatment sessions only a limited correction should be made.In contrast to other wrinkle fillers, SCULPTRA® Aesthetic provides a gradual correction of a contour deficiency overseveral weeks.

7.Massage During the Treating Injection

The treatment area should be massaged in a circular fashion after every3–4 injections to evenly distribute the product.

8.Degree of Correction

The contour deficiency should be under-corrected, never fully correctedor overcorrected (overfilled) during any injection session. Under-correction ofthe treatment area allows for gradual improvement of the contour deficiency asthe SCULPTRA® Aesthetic effect occurs over the minimum ofthree weeks between assessment and possible next injection session.

9.Post-treatment Care

Immediately after a SCULPTRA® Aestheticinjection session, redness, swelling, and/or bruising may appear in thetreatment area. See ADVERSEEVENTS fordetails of the incidence and severity of adverse event observed immediatelypost-injection during the clinical trial. To help SCULPTRA® Aesthetic distribute evenly in the contourdeficiency, it is important at the end of the treatment

session to manually massage in a circular fashion the treatment area fora minimum of 2 minutes. A facial moisturizer should be used to perform themassage.

It is recommended that the patient should massage the treated areas forfive minutes, five times per day for five days after the injection session to promote a natural-looking correction. Toreduce the risk of edema and/or bruising after injection, an ice pack (avoidany direct contact of the ice with the skin) is applied to the treated areas.

Early occurrence of subcutaneousnodules at the injection site (within 3 to 6 weeks after the treatment) may beminimized by adhering to proper dilution and injection techniques (e.g.,avoiding superficial injections or over-correction). In addition, massaging thetreatment area to ensure proper distribution of the product may also minimizethe appearance of nodules. Nodules usually resolve spontaneously. However, asreported in published literature, some nodules may require medical treatmentsuch as subcision (break-up of nodules with sterile saline solution), anddelayed occurrence of subcutaneous nodules at the injection site (usually willmanifest within 3 to 4 months after the treatment) may require treatment suchas intralesional injections of corticosteroids, subcision and/or excision.

10. Treat, Wait, Assess

During the first injection session with SCULPTRA® Aesthetic, only a limited correction should be made. The contourdeficiency should be under-corrected, never fully corrected or overcorrected(overfilled) during any injection session. Re-evaluate the patient no soonerthan three weeks after the injection session to determine if additionalcorrection is needed. The patient should be advised before and after aninjection, that typically at the end of the injection session, it is expectedto experience some degree of swelling associated with the injection procedureitself. This will give the appearance of a full correction by the end of theinjection session and this injection-related swelling typically resolves inseveral hours to a few days. For this reason, the original contour deficiencymay initially reappear, but the deficiency is expected to gradually improvewithin several weeks of SCULPTRA Aesthetic injection as the effect occurs. Thepatient should be advised of the potential need for up to four injectionsessions (typically three) at the first consultation.

Record Keeping:

The AUTHORIZEDLICENSED MEDICAL PERSONNEL shall be responsible for maintainingSCULPTRA® injection treatment records, including butnot limited to client assessment; Good Faith Exam; signed informed consent ofrisks, benefits, and potential adverse effects; number of treatments; treatmentsites; number of injections; solution/concentration used; and the clientresponse to treatment. The injectable facial drawing should be completed.

Requirements for the Authorized Licensed Medical Personnel:

I) TRAINING/EDUCATION

The AUTHORIZEDLICENSED MEDICAL PERSONNEL shall receive specialized training (and becertified) in the administration of Injectable SCULPTRA®.A Physician, Doctor of Osteopath, Advanced Practice Nurse experienced inthis procedure, or a teaching institution specializing in this procedure, mayperform this training and certification.

Competencies to successfully demonstrate shall include:

·      Mechanism of Action of SCULPTRA®

·      Basic Theory of SCULPTRA®Treatments for Cosmetic Purposes

·      Facial Anatomy

·      Safety, efficacy, and complication issues

·      Assessment and identification of areas to betreated

·      Safe application of injection techniques

II) COMPETENCIES & DOCUMENTATION:

The Beverly Hills Rejuvenation Center LOCATION NAME MedicalDirector:

·      Evaluate the competence of the AUTHORIZEDLICENSED MEDICAL PERSONNEL on an as-needed basis if indicated by clientdissatisfaction or efficacy issues.

·      The Beverly Hills Rejuvenation Center LOCATION NAME Administrator shallmaintain a record of medical staff's training and certifications. MedicalDirector shall periodically evaluate competencies of the medical staff.

·      Review 10% of all Injectable Filler charts toensure safety and efficacy of treatments.

Development & Approvalof Standardized Procedure:

This clinical policy and procedure for theadministration of SCULPTRA® Aesthetichas been developed jointly by the Medical Director and NursePractitioner at Beverly Hills Rejuvenation Center ADDRESS, and theofficial package insert from the company. This procedure will bereviewed on an annual and as-needed basis, and documentation pertinent to thereview will be kept on file in the designated administrative office.

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