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A Recommended Approach to Cosmetic Enhancement with Sculptra

October 2007

 

To achieve the best outcomes, with minimal adverse effects, with poly-L-lactic acid (Sculptra), we offer our best practices, including patient selection, treatment planning, and avoiding adverse events, as well as our recommended injection methods.

 

 

 

Careful Patient Selection and Proper Training

To obtain the most natural results with Sculptra, it is important to become properly trained in the correct administration technique. Careful patient selection is also a factor in achieving a good treatment outcome. For example, patients older than 60 years may need a greater number of treatments for optimal facial augmentation because their ability to produce fibroblasts for creating collagen is diminished.1
 

Planning Treatment Regimen

Factors such as age and the area of correction should be taken into account when planning a treatment regimen.2
In general, the number of injections per session and total volume of correction is determined by the size of the area to be corrected.

For example, if lipoatrophy is particularly severe, a cheek may require as many as 20 injections of 0.1 to 0.2 ml each.2
Small marks can be made with a water-soluble surgical pen around the area to be injected. Marks should be made with the patient in the sitting position to better assess facial laxity.
 

Recommended Injection Technique

Two types of injection techniques are recommended for Sculptra and are known as threading/tunneling and depot.

The threading or tunneling technique (See Figures 1 and 2) is the most appropriate technique for the mid and lower face (cheek, preauricular and malar regions) and should be administered in a cross-hatching type pattern (See Figure 1) to more evenly cover the desired treatment area and avoid any skip areas.3 In this area, the needle should be inserted into the deep dermis or the junction with the upper subcutaneous layer at a 30- to 40-degree angle, followed by lowering of the needle to inject parallel to the skin.4 A change in tissue resistance should be felt as the needle traverses the dermal–subcutaneous junction.5 Sculptra is injected as the needle is withdrawn in a retrograde fashion, stopping short of the superficial dermal layer.

 

 

The depot technique (Figure 1, above) is recommended for other areas, such as the temples or upper zygoma. Specifically for the infraorbital area, Sculptra injection should be reduced to small boluses of 0.05 ml per injection. The needle should be placed below the obicularis oculi muscle, depositing the product just above the periosteum.5 In the temples, the needle should be inserted at a 45-degree angle, with the final product placed below the level of the temporalis muscle fascia. When injecting, it is important to use a reflux maneuver before depositing Sculptra to ensure that a blood vessel has not been entered.3
 

Avoiding Overcorrection

To avoid overcorrection in general, a minimal amount of product should be used for each injection (0.1 to 0.2 ml), and each injection site should be spaced at 0.5- to 1-cm intervals apart.6 Of note, deeper areas are corrected with additional treatment sessions rather than additional product at the initial treatment, to avoid an over-abundant formation of collagen in that area. Injections are carried out with a minimum 25- or 26-gauge needle and the treated area should be massaged following every two to three injections.3

Patients should also be advised to massage the treatment area periodically for several weeks after treatment. Lidocaine may be added to the product immediately prior to use to increase patient comfort.
 

Adverse Events

Possible adverse events common with all injectable products may include tissue response to the injection procedure itself. Adverse events may relate to the properties of the product used or the technique of administration.7 In key studies for Sculptra, subcutaneous papules were found in 44%,8 31%,9 6.1%10 and 13.1%11 of the patients. In the majority of cases, non-visible subcutaneous papules gradually and spontaneously resolved over time.12

Recently published data have shown that in 2,131 patients receiving Sculptra for facial augmentation, hand rejuvenation and acne scar treatment, the development of non-visible subcutaneous papules (<5 mm) was relatively low and was seen in just 3.2% of patients, of which 26.9% spontaneously resolved within 3 months.12 Much more rarely, visible subcutaneous papules have been reported after facial injections (1.2%) and injections into other parts of the body (0.38%).12

Steps to Avoiding Adverse Events

The risk of adverse events associated with Sculptra is minimized if appropriate pre-injection and injection procedures are employed.
The area selected for treatment should be appropriate; injections to the periorbital area should be reserved for experienced injectors, and injections should be avoided in areas such as the lips, neck or glabella.
A minimum of 2 weeks is recommended between each treatment, as this allows the physician to properly assess the needs of the patient and the effects of the treatment. However, clinical experience has shown it is best to wait 4 to 6 weeks between treatment sessions.
It is also important that Sculptra is properly reconstituted, as non-homogeneous reconstitution of Sculptra or injection less than 2 hours after reconstitution have both been associated with an increased risk of side effects. It has been found that nodule formation may be associated with high concentrations of localized Sculptra (i.e., dilution of the contents of one vial with 3 ml sterile water for injection [SWFI]). Published information also suggests that additional dilution time (24 hours) beyond the 2-hour minimum may further decrease the risk of papule formation.6 Therefore, a recommended technique is to dilute Sculptra with 5 ml SWFI and to reconstitute for more than 2 hours prior to use. Again, additional dilution time may be beneficial.
Administration should be by deep dermal/subcutaneous injection.
• Finally, to ensure that the product is evenly dispersed throughout the tissues, the injection area should always be massaged post-treatment. By avoiding a localized accumulation of Sculptra, the risk of papule formation and foreign body reactions will be minimized.

Ensuring Success with this dermal filler

It is important that the correct overall injection technique is employed when using PLLA, including proper reconstitution and injection, massage and enough time between treatments to evaluate the effects. This will allow the physician to achieve the best natural-looking result with minimal adverse events.

 

 

 

 

 

 

 

 

 

To achieve the best outcomes, with minimal adverse effects, with poly-L-lactic acid (Sculptra), we offer our best practices, including patient selection, treatment planning, and avoiding adverse events, as well as our recommended injection methods.

 

 

 

Careful Patient Selection and Proper Training

To obtain the most natural results with Sculptra, it is important to become properly trained in the correct administration technique. Careful patient selection is also a factor in achieving a good treatment outcome. For example, patients older than 60 years may need a greater number of treatments for optimal facial augmentation because their ability to produce fibroblasts for creating collagen is diminished.1
 

Planning Treatment Regimen

Factors such as age and the area of correction should be taken into account when planning a treatment regimen.2
In general, the number of injections per session and total volume of correction is determined by the size of the area to be corrected.

For example, if lipoatrophy is particularly severe, a cheek may require as many as 20 injections of 0.1 to 0.2 ml each.2
Small marks can be made with a water-soluble surgical pen around the area to be injected. Marks should be made with the patient in the sitting position to better assess facial laxity.
 

Recommended Injection Technique

Two types of injection techniques are recommended for Sculptra and are known as threading/tunneling and depot.

The threading or tunneling technique (See Figures 1 and 2) is the most appropriate technique for the mid and lower face (cheek, preauricular and malar regions) and should be administered in a cross-hatching type pattern (See Figure 1) to more evenly cover the desired treatment area and avoid any skip areas.3 In this area, the needle should be inserted into the deep dermis or the junction with the upper subcutaneous layer at a 30- to 40-degree angle, followed by lowering of the needle to inject parallel to the skin.4 A change in tissue resistance should be felt as the needle traverses the dermal–subcutaneous junction.5 Sculptra is injected as the needle is withdrawn in a retrograde fashion, stopping short of the superficial dermal layer.

 

 

The depot technique (Figure 1, above) is recommended for other areas, such as the temples or upper zygoma. Specifically for the infraorbital area, Sculptra injection should be reduced to small boluses of 0.05 ml per injection. The needle should be placed below the obicularis oculi muscle, depositing the product just above the periosteum.5 In the temples, the needle should be inserted at a 45-degree angle, with the final product placed below the level of the temporalis muscle fascia. When injecting, it is important to use a reflux maneuver before depositing Sculptra to ensure that a blood vessel has not been entered.3
 

Avoiding Overcorrection

To avoid overcorrection in general, a minimal amount of product should be used for each injection (0.1 to 0.2 ml), and each injection site should be spaced at 0.5- to 1-cm intervals apart.6 Of note, deeper areas are corrected with additional treatment sessions rather than additional product at the initial treatment, to avoid an over-abundant formation of collagen in that area. Injections are carried out with a minimum 25- or 26-gauge needle and the treated area should be massaged following every two to three injections.3

Patients should also be advised to massage the treatment area periodically for several weeks after treatment. Lidocaine may be added to the product immediately prior to use to increase patient comfort.
 

Adverse Events

Possible adverse events common with all injectable products may include tissue response to the injection procedure itself. Adverse events may relate to the properties of the product used or the technique of administration.7 In key studies for Sculptra, subcutaneous papules were found in 44%,8 31%,9 6.1%10 and 13.1%11 of the patients. In the majority of cases, non-visible subcutaneous papules gradually and spontaneously resolved over time.12

Recently published data have shown that in 2,131 patients receiving Sculptra for facial augmentation, hand rejuvenation and acne scar treatment, the development of non-visible subcutaneous papules (<5 mm) was relatively low and was seen in just 3.2% of patients, of which 26.9% spontaneously resolved within 3 months.12 Much more rarely, visible subcutaneous papules have been reported after facial injections (1.2%) and injections into other parts of the body (0.38%).12

Steps to Avoiding Adverse Events

The risk of adverse events associated with Sculptra is minimized if appropriate pre-injection and injection procedures are employed.
The area selected for treatment should be appropriate; injections to the periorbital area should be reserved for experienced injectors, and injections should be avoided in areas such as the lips, neck or glabella.
A minimum of 2 weeks is recommended between each treatment, as this allows the physician to properly assess the needs of the patient and the effects of the treatment. However, clinical experience has shown it is best to wait 4 to 6 weeks between treatment sessions.
It is also important that Sculptra is properly reconstituted, as non-homogeneous reconstitution of Sculptra or injection less than 2 hours after reconstitution have both been associated with an increased risk of side effects. It has been found that nodule formation may be associated with high concentrations of localized Sculptra (i.e., dilution of the contents of one vial with 3 ml sterile water for injection [SWFI]). Published information also suggests that additional dilution time (24 hours) beyond the 2-hour minimum may further decrease the risk of papule formation.6 Therefore, a recommended technique is to dilute Sculptra with 5 ml SWFI and to reconstitute for more than 2 hours prior to use. Again, additional dilution time may be beneficial.
Administration should be by deep dermal/subcutaneous injection.
• Finally, to ensure that the product is evenly dispersed throughout the tissues, the injection area should always be massaged post-treatment. By avoiding a localized accumulation of Sculptra, the risk of papule formation and foreign body reactions will be minimized.

Ensuring Success with this dermal filler

It is important that the correct overall injection technique is employed when using PLLA, including proper reconstitution and injection, massage and enough time between treatments to evaluate the effects. This will allow the physician to achieve the best natural-looking result with minimal adverse events.

 

 

 

 

 

 

 

 

 

To achieve the best outcomes, with minimal adverse effects, with poly-L-lactic acid (Sculptra), we offer our best practices, including patient selection, treatment planning, and avoiding adverse events, as well as our recommended injection methods.

 

 

 

Careful Patient Selection and Proper Training

To obtain the most natural results with Sculptra, it is important to become properly trained in the correct administration technique. Careful patient selection is also a factor in achieving a good treatment outcome. For example, patients older than 60 years may need a greater number of treatments for optimal facial augmentation because their ability to produce fibroblasts for creating collagen is diminished.1
 

Planning Treatment Regimen

Factors such as age and the area of correction should be taken into account when planning a treatment regimen.2
In general, the number of injections per session and total volume of correction is determined by the size of the area to be corrected.

For example, if lipoatrophy is particularly severe, a cheek may require as many as 20 injections of 0.1 to 0.2 ml each.2
Small marks can be made with a water-soluble surgical pen around the area to be injected. Marks should be made with the patient in the sitting position to better assess facial laxity.
 

Recommended Injection Technique

Two types of injection techniques are recommended for Sculptra and are known as threading/tunneling and depot.

The threading or tunneling technique (See Figures 1 and 2) is the most appropriate technique for the mid and lower face (cheek, preauricular and malar regions) and should be administered in a cross-hatching type pattern (See Figure 1) to more evenly cover the desired treatment area and avoid any skip areas.3 In this area, the needle should be inserted into the deep dermis or the junction with the upper subcutaneous layer at a 30- to 40-degree angle, followed by lowering of the needle to inject parallel to the skin.4 A change in tissue resistance should be felt as the needle traverses the dermal–subcutaneous junction.5 Sculptra is injected as the needle is withdrawn in a retrograde fashion, stopping short of the superficial dermal layer.

 

 

The depot technique (Figure 1, above) is recommended for other areas, such as the temples or upper zygoma. Specifically for the infraorbital area, Sculptra injection should be reduced to small boluses of 0.05 ml per injection. The needle should be placed below the obicularis oculi muscle, depositing the product just above the periosteum.5 In the temples, the needle should be inserted at a 45-degree angle, with the final product placed below the level of the temporalis muscle fascia. When injecting, it is important to use a reflux maneuver before depositing Sculptra to ensure that a blood vessel has not been entered.3
 

Avoiding Overcorrection

To avoid overcorrection in general, a minimal amount of product should be used for each injection (0.1 to 0.2 ml), and each injection site should be spaced at 0.5- to 1-cm intervals apart.6 Of note, deeper areas are corrected with additional treatment sessions rather than additional product at the initial treatment, to avoid an over-abundant formation of collagen in that area. Injections are carried out with a minimum 25- or 26-gauge needle and the treated area should be massaged following every two to three injections.3

Patients should also be advised to massage the treatment area periodically for several weeks after treatment. Lidocaine may be added to the product immediately prior to use to increase patient comfort.
 

Adverse Events

Possible adverse events common with all injectable products may include tissue response to the injection procedure itself. Adverse events may relate to the properties of the product used or the technique of administration.7 In key studies for Sculptra, subcutaneous papules were found in 44%,8 31%,9 6.1%10 and 13.1%11 of the patients. In the majority of cases, non-visible subcutaneous papules gradually and spontaneously resolved over time.12

Recently published data have shown that in 2,131 patients receiving Sculptra for facial augmentation, hand rejuvenation and acne scar treatment, the development of non-visible subcutaneous papules (<5 mm) was relatively low and was seen in just 3.2% of patients, of which 26.9% spontaneously resolved within 3 months.12 Much more rarely, visible subcutaneous papules have been reported after facial injections (1.2%) and injections into other parts of the body (0.38%).12

Steps to Avoiding Adverse Events

The risk of adverse events associated with Sculptra is minimized if appropriate pre-injection and injection procedures are employed.
The area selected for treatment should be appropriate; injections to the periorbital area should be reserved for experienced injectors, and injections should be avoided in areas such as the lips, neck or glabella.
A minimum of 2 weeks is recommended between each treatment, as this allows the physician to properly assess the needs of the patient and the effects of the treatment. However, clinical experience has shown it is best to wait 4 to 6 weeks between treatment sessions.
It is also important that Sculptra is properly reconstituted, as non-homogeneous reconstitution of Sculptra or injection less than 2 hours after reconstitution have both been associated with an increased risk of side effects. It has been found that nodule formation may be associated with high concentrations of localized Sculptra (i.e., dilution of the contents of one vial with 3 ml sterile water for injection [SWFI]). Published information also suggests that additional dilution time (24 hours) beyond the 2-hour minimum may further decrease the risk of papule formation.6 Therefore, a recommended technique is to dilute Sculptra with 5 ml SWFI and to reconstitute for more than 2 hours prior to use. Again, additional dilution time may be beneficial.
Administration should be by deep dermal/subcutaneous injection.
• Finally, to ensure that the product is evenly dispersed throughout the tissues, the injection area should always be massaged post-treatment. By avoiding a localized accumulation of Sculptra, the risk of papule formation and foreign body reactions will be minimized.

Ensuring Success with this dermal filler

It is important that the correct overall injection technique is employed when using PLLA, including proper reconstitution and injection, massage and enough time between treatments to evaluate the effects. This will allow the physician to achieve the best natural-looking result with minimal adverse events.