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A Prospective, Comparative, Evaluator-blind Clinical Study Investigating Efficacy and Safety of Two Injection Techniques with Radiesse(®) for the Correction of Skin Changes in Aging Hands.

Gubanova EI, Starovatova PA - J Cutan Aesthet Surg (2015 Jul-Sep)

Bottom Line: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse(®).The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30).Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse(®).

View Article: PubMed Central - PubMed

Affiliation: Vallex M Clinic of Preventive Medicine, Moscow National University of Food Production, Moscow, Russia ; Department of Skin and Venereal Diseases, Postgraduate Medical Institute, Moscow National University of Food Production, Moscow, Russia.

ABSTRACT

Background: Dermal fillers are used to correct age-related changes in hands.

Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse(®).

Settings and design: This was a prospective, comparative, evaluator-blind, single-center study.

Materials and methods: Radiesse(®) (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs).

Statistical analysis used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively.

Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse(®)). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported.

Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse(®).

No MeSH data available.


Related in: MedlinePlus

Injection techniques used during the study. (A) 1.0 mL of Radiesse®-lidocaine injected into one hand using multiple injection sites using a needle (N hand); (B) 1.0 mL of Radiesse®-lidocaine injected into one hand using a fan-like distribution pattern with a blunt cannula (C hand). Typically, 6-8 distribution points (arrows) are used per hand
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Figure 2: Injection techniques used during the study. (A) 1.0 mL of Radiesse®-lidocaine injected into one hand using multiple injection sites using a needle (N hand); (B) 1.0 mL of Radiesse®-lidocaine injected into one hand using a fan-like distribution pattern with a blunt cannula (C hand). Typically, 6-8 distribution points (arrows) are used per hand

Mentions: A topical anesthetic (EMLA® 5% cream; AstraZeneca AB, Sweden) was applied to the hands of each participant, 20 minutes before injection. With their vision obscured, participants were injected in one hand (N hand) with 0.8 mL Radiesse® mixed with 0.2 mL 2% lidocaine solution using uniform multipoint needle (27 G) injections [Figure 2a]. In the other hand (C hand), injections were performed using a blunt cannula (25 G; 50 mm) in the upper subdermal layer (depth of 2-3 mm) in a fan-like distribution [Figure 2b]. Following each injection, hands were massaged.


A Prospective, Comparative, Evaluator-blind Clinical Study Investigating Efficacy and Safety of Two Injection Techniques with Radiesse(®) for the Correction of Skin Changes in Aging Hands.

Gubanova EI, Starovatova PA - J Cutan Aesthet Surg (2015 Jul-Sep)

Injection techniques used during the study. (A) 1.0 mL of Radiesse®-lidocaine injected into one hand using multiple injection sites using a needle (N hand); (B) 1.0 mL of Radiesse®-lidocaine injected into one hand using a fan-like distribution pattern with a blunt cannula (C hand). Typically, 6-8 distribution points (arrows) are used per hand
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4645144&req=5

Figure 2: Injection techniques used during the study. (A) 1.0 mL of Radiesse®-lidocaine injected into one hand using multiple injection sites using a needle (N hand); (B) 1.0 mL of Radiesse®-lidocaine injected into one hand using a fan-like distribution pattern with a blunt cannula (C hand). Typically, 6-8 distribution points (arrows) are used per hand
Mentions: A topical anesthetic (EMLA® 5% cream; AstraZeneca AB, Sweden) was applied to the hands of each participant, 20 minutes before injection. With their vision obscured, participants were injected in one hand (N hand) with 0.8 mL Radiesse® mixed with 0.2 mL 2% lidocaine solution using uniform multipoint needle (27 G) injections [Figure 2a]. In the other hand (C hand), injections were performed using a blunt cannula (25 G; 50 mm) in the upper subdermal layer (depth of 2-3 mm) in a fan-like distribution [Figure 2b]. Following each injection, hands were massaged.

Bottom Line: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse(®).The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30).Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse(®).

View Article: PubMed Central - PubMed

Affiliation: Vallex M Clinic of Preventive Medicine, Moscow National University of Food Production, Moscow, Russia ; Department of Skin and Venereal Diseases, Postgraduate Medical Institute, Moscow National University of Food Production, Moscow, Russia.

ABSTRACT

Background: Dermal fillers are used to correct age-related changes in hands.

Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse(®).

Settings and design: This was a prospective, comparative, evaluator-blind, single-center study.

Materials and methods: Radiesse(®) (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs).

Statistical analysis used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively.

Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse(®)). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported.

Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse(®).

No MeSH data available.


Related in: MedlinePlus