MATERIALS AND METHODS
This was a 48-week, randomized, evaluator-blinded, parallelgroup, multi-center study (NCT03780244).
Subjects
Subjects were randomized 2:1 to treatment with Sculptra Aesthetic reconstituted with 8 mL (treatment group) or 5 mL (reference group) SWFI. In addition, 8 subjects with Fitzpatrick skin type (FST) IV and 8 subjects with FST V–VI were included in the treatment group but not randomized. Eligible subjects were ≥22 years of age and had nasolabial fold contour deficiencies with a Wrinkle Assessment Scale (WAS)11 score between 2 (shallow wrinkle) and 4 (deep wrinkle) on left and right nasolabial fold (1-grade difference between sides was allowed). Subjects provided a written informed consent for participation in the study. Main exclusion criteria included contouring or revitalization treatment in or near the treatment area with collagen or hyaluronic acid within the previous 12 months, and calcium hydroxylapatite, poly-L-lactic acid or permanent filler(s) at any time prior to enrollment. Subjects had follow-up visits at weeks 16, 24, 32, 40, and 48.
Treatment
For the treatment group, Sculptra Aesthetic was reconstituted prior to use by addition of 8 mL SWFI and an additional 1 mL of 2%-lidocaine hydrochloride for a total volume of 9 mL. The vial was shaken vigorously for about 1 minute after adding SWFI, and no standing time was required before injection. For the reference group, Sculptra Aesthetic was reconstituted by adding 5 mL of SWFI. No lidocaine was added to the solution, but a local anesthetic could be used topically or injected separately. Two to 72 hours standing time was required. Characteristics for the study groups are presented in Table 1. All randomized subjects received a single treatment regimen consisting of up to 4 injection sessions with 4-week intervals. Subjects were treated on day 1 with up to 1 vial; a maximum of 4.5 mL per nasolabial fold per injection session was used in the treatment group and a maximum of 2.5 mL per side was used in the reference group. Dose amounts allowed were the same for all injection sessions. Subjects were treated to optimal correction, defined as grade 0 (no wrinkles) or grade 1 (just perceptible wrinkles) on the WAS. Injection technique was the same for both groups; Sculptra Aesthetic was injected in the subdermal regions (ie, subcutaneously or supraperiosteally), and injections were made using the bolus, fanning, linear-threading, or other techniques (at the discretion of the treating investigator), using a 25-gauge needle. Aseptic technique and standard practice to prevent cross-infections was to be observed at all times during the procedure.
Assessments
Primary endpoint for effectiveness was change from baseline on both sides of the face as assessed by blinded evaluation using WAS 48 weeks after the first injection. For the primary endpoint to be met, both right and left nasolabial folds had to be statistically significant less than 0 for the treatment group, and the 95% CIs for both groups should overlap to confirm comparable treatment effects. Secondary endpoints for effectiveness included:
• Change from baseline on both sides of the face as assessed by blinded evaluation using WAS. Right and left nasolabial folds were assessed separately and WAS scoring was based on visual live assessment. A responder was defined as having at least 1-grade improvement from baseline on both sides of the face.
• Aesthetic improvement (Improved/Much improved/Very much improved) of right and left nasolabial fold compared to baseline was assessed by subjects and the treating investigator using Global Aesthetic Improvement Scale (GAIS).
• FACE-Q™ appraisal of lines: Nasolabial fold questionnaire was filled out to assess treatment outcome from the subject’s perspective. The sum of the scores was converted to a Rasch-transformed total score where a higher total score indicated greater subject satisfaction.
• Subject satisfaction with treatment results was assessed using a 5-point questionnaire.
Endpoints for safety included:
• Pre-defined, expected, post-treatment symptoms, ie, pain, tenderness, redness, bruising, swelling, itching, and lumps/ bumps, were collected using subject diaries for 28 days following each injection session.
• Adverse events were collected throughout the study; seriousness and casual relationship with study product and/or injection procedure was assessed. In addition, the investigator was to determine if a suspected lesion
Subjects
Subjects were randomized 2:1 to treatment with Sculptra Aesthetic reconstituted with 8 mL (treatment group) or 5 mL (reference group) SWFI. In addition, 8 subjects with Fitzpatrick skin type (FST) IV and 8 subjects with FST V–VI were included in the treatment group but not randomized. Eligible subjects were ≥22 years of age and had nasolabial fold contour deficiencies with a Wrinkle Assessment Scale (WAS)11 score between 2 (shallow wrinkle) and 4 (deep wrinkle) on left and right nasolabial fold (1-grade difference between sides was allowed). Subjects provided a written informed consent for participation in the study. Main exclusion criteria included contouring or revitalization treatment in or near the treatment area with collagen or hyaluronic acid within the previous 12 months, and calcium hydroxylapatite, poly-L-lactic acid or permanent filler(s) at any time prior to enrollment. Subjects had follow-up visits at weeks 16, 24, 32, 40, and 48.
Treatment
For the treatment group, Sculptra Aesthetic was reconstituted prior to use by addition of 8 mL SWFI and an additional 1 mL of 2%-lidocaine hydrochloride for a total volume of 9 mL. The vial was shaken vigorously for about 1 minute after adding SWFI, and no standing time was required before injection. For the reference group, Sculptra Aesthetic was reconstituted by adding 5 mL of SWFI. No lidocaine was added to the solution, but a local anesthetic could be used topically or injected separately. Two to 72 hours standing time was required. Characteristics for the study groups are presented in Table 1. All randomized subjects received a single treatment regimen consisting of up to 4 injection sessions with 4-week intervals. Subjects were treated on day 1 with up to 1 vial; a maximum of 4.5 mL per nasolabial fold per injection session was used in the treatment group and a maximum of 2.5 mL per side was used in the reference group. Dose amounts allowed were the same for all injection sessions. Subjects were treated to optimal correction, defined as grade 0 (no wrinkles) or grade 1 (just perceptible wrinkles) on the WAS. Injection technique was the same for both groups; Sculptra Aesthetic was injected in the subdermal regions (ie, subcutaneously or supraperiosteally), and injections were made using the bolus, fanning, linear-threading, or other techniques (at the discretion of the treating investigator), using a 25-gauge needle. Aseptic technique and standard practice to prevent cross-infections was to be observed at all times during the procedure.
Assessments
Primary endpoint for effectiveness was change from baseline on both sides of the face as assessed by blinded evaluation using WAS 48 weeks after the first injection. For the primary endpoint to be met, both right and left nasolabial folds had to be statistically significant less than 0 for the treatment group, and the 95% CIs for both groups should overlap to confirm comparable treatment effects. Secondary endpoints for effectiveness included:
• Change from baseline on both sides of the face as assessed by blinded evaluation using WAS. Right and left nasolabial folds were assessed separately and WAS scoring was based on visual live assessment. A responder was defined as having at least 1-grade improvement from baseline on both sides of the face.
• Aesthetic improvement (Improved/Much improved/Very much improved) of right and left nasolabial fold compared to baseline was assessed by subjects and the treating investigator using Global Aesthetic Improvement Scale (GAIS).
• FACE-Q™ appraisal of lines: Nasolabial fold questionnaire was filled out to assess treatment outcome from the subject’s perspective. The sum of the scores was converted to a Rasch-transformed total score where a higher total score indicated greater subject satisfaction.
• Subject satisfaction with treatment results was assessed using a 5-point questionnaire.
Endpoints for safety included:
• Pre-defined, expected, post-treatment symptoms, ie, pain, tenderness, redness, bruising, swelling, itching, and lumps/ bumps, were collected using subject diaries for 28 days following each injection session.
• Adverse events were collected throughout the study; seriousness and casual relationship with study product and/or injection procedure was assessed. In addition, the investigator was to determine if a suspected lesion
