countries, treatment data from Asian patients, in particular from long-term follow-up is needed. This study evaluated safety and effectiveness of HAR and HARL, when used for full-face treatment including upper cheeks, nasolabial folds, temples, chin, and nose in an Asian population. Assessments included well-defined outcome scales and blinded/independent evaluators, reducing the risk of bias.
The study provides further support to aesthetic improvement from using HAR and HARL, as 95% of subjects were improved on the primary endpoint; subject-assessed GAIS 6 months after first treatment. This improvement was confirmed by investigators. The proportion of improved subjects remained high throughout the study (≥82%), as assessed both by subjects and investigators. Also, according to blinded evaluators, at least 70% of subjects were improved during the 24-month study period.
Subject expectations with treatment were met to a high degree, as satisfaction with facial appearance increased from 15% at baseline to 88% three months after first treatment. Comparably low mean injection volumes for a full-face treatment (4.7 and 3.1 mL including touch-up at first and second treatment, respectively), was still associated with high subject satisfaction, that remained throughout the 24-month study.
Although subjects were treated for an overall facial aesthetic improvement, there were indeed improvement reported for specific treatment areas. Upper cheek fullness, assessed by investigators, showed improvement for ≥66% of subjects up to 6 months after each treatment. Characteristic for upper cheeks was the significantly higher improvement rate observed 12 months after second treatment than 12 months after first treatment (≥69% vs 38% improved subjects). A previous study by Weiss et al6 used a mean volume of 6.23 mL HARL for treating midface at the initial treatment, whereas in the current study, the total mean volume for both treatments was 3.5 mL for cheeks. This smaller volume still resulted in improvement for a majority of subjects at most timepoints. Nasolabial fold improvement was however lower than reported in other studies.12,13 It should be noted though that the current study did not include subjects on the basis of nasolabial fold severity, which therefore could be less at baseline, potentially resulting in lower improvement rate. The blinded evaluators generally rated subjects as less improved compared to investigators on all effectiveness assessments. This can be explained by limitations associated with only using retrospective photographs for assessments. Also, 92–96% of subjects were assessed by the blinded evaluators as having full or only mildly sunken cheeks at baseline, leaving little room for improvement.
Both study products were used in comparable number of subjects and volume used for treating upper cheeks, nasolabial folds and temples. HARL was preferred over HAR for treating nose and chin, all in line with the intended use for the firmer gel in areas requiring more support. The chin was a prioritized treatment area in this Asian population, being the most commonly injected area following the mandatory indications upper cheeks and nasolabial folds. From the sub-study on subjects treated in the chin, GAIS improvement rates were high at all timepoints (≥90%) both from 2D, and 3D-photograph evaluations. Although subjects were not treated specifically for chin retrusion or jawline sagging, long-term improvement 12 months after treatment increased with the second treatment for GCRS (63% vs 38% improved subjects) and to some extent for JSS (52% vs 41%).
Reporting of local tolerability symptoms from subject diaries was generally declining three days after both first and second treatment. Product/treatment related adverse events were predominantly mild and transient. The frequency of related adverse events decreased with the second treatment (9 events compared to 20 events after first treatment). Overall, pain (13 events in 5 subjects [5%]) and bruising (7 events in 6 subjects [6%]) were most commonly reported, both being known local site reactions after HA filler injections.12,14 No new safety findings were reported in the study.
The study provides further support to aesthetic improvement from using HAR and HARL, as 95% of subjects were improved on the primary endpoint; subject-assessed GAIS 6 months after first treatment. This improvement was confirmed by investigators. The proportion of improved subjects remained high throughout the study (≥82%), as assessed both by subjects and investigators. Also, according to blinded evaluators, at least 70% of subjects were improved during the 24-month study period.
Subject expectations with treatment were met to a high degree, as satisfaction with facial appearance increased from 15% at baseline to 88% three months after first treatment. Comparably low mean injection volumes for a full-face treatment (4.7 and 3.1 mL including touch-up at first and second treatment, respectively), was still associated with high subject satisfaction, that remained throughout the 24-month study.
Although subjects were treated for an overall facial aesthetic improvement, there were indeed improvement reported for specific treatment areas. Upper cheek fullness, assessed by investigators, showed improvement for ≥66% of subjects up to 6 months after each treatment. Characteristic for upper cheeks was the significantly higher improvement rate observed 12 months after second treatment than 12 months after first treatment (≥69% vs 38% improved subjects). A previous study by Weiss et al6 used a mean volume of 6.23 mL HARL for treating midface at the initial treatment, whereas in the current study, the total mean volume for both treatments was 3.5 mL for cheeks. This smaller volume still resulted in improvement for a majority of subjects at most timepoints. Nasolabial fold improvement was however lower than reported in other studies.12,13 It should be noted though that the current study did not include subjects on the basis of nasolabial fold severity, which therefore could be less at baseline, potentially resulting in lower improvement rate. The blinded evaluators generally rated subjects as less improved compared to investigators on all effectiveness assessments. This can be explained by limitations associated with only using retrospective photographs for assessments. Also, 92–96% of subjects were assessed by the blinded evaluators as having full or only mildly sunken cheeks at baseline, leaving little room for improvement.
Both study products were used in comparable number of subjects and volume used for treating upper cheeks, nasolabial folds and temples. HARL was preferred over HAR for treating nose and chin, all in line with the intended use for the firmer gel in areas requiring more support. The chin was a prioritized treatment area in this Asian population, being the most commonly injected area following the mandatory indications upper cheeks and nasolabial folds. From the sub-study on subjects treated in the chin, GAIS improvement rates were high at all timepoints (≥90%) both from 2D, and 3D-photograph evaluations. Although subjects were not treated specifically for chin retrusion or jawline sagging, long-term improvement 12 months after treatment increased with the second treatment for GCRS (63% vs 38% improved subjects) and to some extent for JSS (52% vs 41%).
Reporting of local tolerability symptoms from subject diaries was generally declining three days after both first and second treatment. Product/treatment related adverse events were predominantly mild and transient. The frequency of related adverse events decreased with the second treatment (9 events compared to 20 events after first treatment). Overall, pain (13 events in 5 subjects [5%]) and bruising (7 events in 6 subjects [6%]) were most commonly reported, both being known local site reactions after HA filler injections.12,14 No new safety findings were reported in the study.
CONCLUSION
The study results indicate that HAR and HARL is effective for fullface
treatment in Asian patients, demonstrated by long-term
aesthetic improvement and high subject satisfaction over 24
months with one re-treatment. Repeated treatment in several
facial indications was well tolerated. These data may be used as
support when establishing individual treatment plans in Asian
patients.
DISCLOSURES
Dr Huang is a clinical trial investigator for Galderma; Dr Tsai is a clinical trial investigator for Galderma and Allergan.
Funding: Galderma funded the study and provided the study products and medical writing support.
Funding: Galderma funded the study and provided the study products and medical writing support.
ACKNOWLEDGMENT
The authors would like to thank Shannon Humphrey, MD; Kelly
Thong, MD; Allen Huang, MD; and Fang-Wen Tseng, MD for
serving as evaluators in the study. The authors also acknowledge
Maria Norberg, PhD for medical writing assistance.
REFERENCES
1. Hedén P, Fagrell D, Jernbeck J, et al. Injection of stabilized hyaluronic acid-based gel of non-animal origin for the correction of nasolabial folds: comparison with and without lidocaine. Dermatol Surg. 2010;36:775-781.
2. Royo de la Torre J, Moreno-Moraga J, Isarria MJ, et al. The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. J Drugs Dermatol. 2013;12(3):e46-52.
3. Bertucci V, Lin X, Axford-Gatley RA, et al. Safety and effectiveness of large gel particle hyaluronic acid with lidocaine for correction of midface volume
2. Royo de la Torre J, Moreno-Moraga J, Isarria MJ, et al. The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. J Drugs Dermatol. 2013;12(3):e46-52.
3. Bertucci V, Lin X, Axford-Gatley RA, et al. Safety and effectiveness of large gel particle hyaluronic acid with lidocaine for correction of midface volume
