Safety And Efficacy Of Princess^® FILLER Lidocaine In The Correction Of Nasolabial Folds

Figures & data

Figure 1 Croma-Pharma nasolabial folds severity rating scale.

Notes: Grade 0 (none/minimal)=no visible or minimal NLFs, 1 (mild)=shallow but visible NLF with a slight indentation, 2 (moderate)=moderately deep NLF, 3 (severe)=very deep NLF with prominent facial feature, 4 (extreme)=extremely deep and long NLF with skin redundancy. Used with permission fromCroma-Pharma. 
Abbreviation: NLF, nasolabial fold.

Figure 2 (A) Proportion of subjects with ≥1 grade improvement in NLF severity based on the NLF-SRS as assessed by the investigator and the independent reviewer of photographs (“reviewer”). (B) Proportion of subjects with ≥2 grades improvement in NLF severity based on the NLF-SRS as assessed by the investigator.

Notes: Percentages are based on the number of subjects in the analysis set (N=60). The evaluation of 1 subject was missing at all post-baseline visits.
Abbreviations: N, number of subjects; NLF, nasolabial fold; NLF-SRS, nasolabial fold-severity rating scale.

Table 1 (%) Of Subjects With ≥1 Grade Reduction Of NLF Severity By At Least 1 Grade On The NLF-SRS As Assessed By The Investigator

Visit	N =60	(%) of Subjects With ≥1 Grade Reduction
Week 4	59	98.3%
Week 24	58	96.7%
Week 36	58	96.7%

Abbreviations: N, number of analyzed subjects; NLF, nasolabial fold; NLF-SRS, nasolabial fold-severity rating scale.

Figure 3 Proportion of subjects with improved aesthetics as assessed by the investigator using the GAIS.

Notes: The GAIS score was averaged over both nasolabial folds. Percentages are based on the number of subjects in the analysis set (N=60). The evaluation of 1 subject was missing at all postbaseline visits.
Abbreviations: GAIS, Global Aesthetic Improvement Scale; N, number of subjects.

Figure 4 Subject satisfaction ratings.

Notes: Percentages are based on the number of subjects in the analysis set (N=60). The evaluation of 1 subject was missing at all post-baseline visits.
Abbreviation: N, number of subjects.

Figure 5 Pain score immediately after injection.

Notes: Percentages of subjects with their Pain Score immediately after injection at Initial treatment and at Touch-up treatment. Percentages are based on the number of subjects in the analysis set (N=60) for the initial treatment and N=20 for touch-up treatment. The evaluation of 1 subject was missing at all post-baseline visits.
Abbreviation: N, number of subjects.

Table 2 Incidence Of ADEs Reported During The Investigation

MedDRA Preferred Terms	N (%)^a	n
Injection site hematoma	16 (26.7)	17
Injection site pain	12 (20.0)	12
Injection site swelling	2 (3.3)	2

Notes: ^aPercentages are based on subjects in the safety analysis set (N=60).

Abbreviations: ADEs, adverse device effects, MedDRA, Medical Dictionary for Regulatory Activities; N, number of subjects; n, number of events.

Figure 6 Clinical photos of treated patients.