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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

The validated 5-point MAS for assessment of age-related skin changes of the hands. Reproduced with permission from Merz Pharmaceuticals GmbH
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Figure 1: The validated 5-point MAS for assessment of age-related skin changes of the hands. Reproduced with permission from Merz Pharmaceuticals GmbH

Mentions: This prospective, comparative, evaluator-blind clinical study was carried out between January 2013 and July 2013 at a single center in Moscow, Russia, and was performed in line with local and international regulations. The study was approved by the local Ethical Committee of Vallex M Clinic, Moscow. All study procedures were carried out in accordance with the Declaration of Helsinki. Women between 40 and 65 years of age, with a score of 1-4 according to the validated Merz Aesthetics Hand Grading Scale (MAS; a 5-point scale for assessment of hands; [Figure 1])[12] and body mass index (BMI) <25 kg/m2 were eligible for inclusion in the study. Informed consent was obtained from each participant. Exclusion criteria included pregnancy; any cosmetic procedures or injections in the treatment area within the last 6 months; previous injections of permanent fillers in the treatment area (including fat transplants); previous surgery or scars on the dorsal area of the hands; and excess of subcutaneous fat or hypertrophy of muscles in the hand.


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)

The validated 5-point MAS for assessment of age-related skin changes of the hands. Reproduced with permission from Merz Pharmaceuticals GmbH
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 1: The validated 5-point MAS for assessment of age-related skin changes of the hands. Reproduced with permission from Merz Pharmaceuticals GmbH
Mentions: This prospective, comparative, evaluator-blind clinical study was carried out between January 2013 and July 2013 at a single center in Moscow, Russia, and was performed in line with local and international regulations. The study was approved by the local Ethical Committee of Vallex M Clinic, Moscow. All study procedures were carried out in accordance with the Declaration of Helsinki. Women between 40 and 65 years of age, with a score of 1-4 according to the validated Merz Aesthetics Hand Grading Scale (MAS; a 5-point scale for assessment of hands; [Figure 1])[12] and body mass index (BMI) <25 kg/m2 were eligible for inclusion in the study. Informed consent was obtained from each participant. Exclusion criteria included pregnancy; any cosmetic procedures or injections in the treatment area within the last 6 months; previous injections of permanent fillers in the treatment area (including fat transplants); previous surgery or scars on the dorsal area of the hands; and excess of subcutaneous fat or hypertrophy of muscles in the hand.

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