Ann Dermatol.  2016 Jun;28(3):297-303. 10.5021/ad.2016.28.3.297.

A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds

• Kim BW
• Moon IJ
• Yun WJ
• Chung BY
• Kim SD
• Lee GY
• Chang SE

• KMID: 2164636
• DOI: http://doi.org/10.5021/ad.2016.28.3.297

Abstract

BACKGROUND
Mannitol containing monophasic filler with higher crosslinking has not been well studied for moderate and severe nasolabial fold (NLF) correction.
OBJECTIVE
To compare the efficacy and safety of a novel mannitol containing hyaluronic acid (HA) filler (HA-G) with biphasic HA filler (HA-P) for moderate and severe NLF correction.
METHODS
Thirteen subjects with symmetric moderate to severe NLF received HA-G (in one NLF) and HA-P (in other NLF) and were evaluated for 24 weeks.
RESULTS
At both 12 and 24 weeks, the mean improvement in Genzyme 6-point grading scale from baseline was significantly greater in the side of face that was treated with HA-G than HA-P (1.96±0.91 vs. 1.54±0.73 at week 12; p=0.044, 1.88±0.78 vs. 1.3±0.79 at week 24; p=0.027, respectively). At 12 weeks, the mean Global Aesthetic Improvement Scale score was 2.92±0.93 for HA-G and 2.31±0.95 for HA-P (p=0.008). Both fillers were well tolerated.
CONCLUSION
The HA filler HA-G provides better efficacy and similar local tolerability compared with HA-P in 6 months following treatment for moderate and severe NLF.

Keyword

Dermal filler; Hyaluronic acid; Mannitol; Nasolabial fold

MeSH Terms

Dermal Fillers*
Hyaluronic Acid*
Mannitol*
Nasolabial Fold*
Dermal Fillers
Hyaluronic Acid
Mannitol

Figure

• 

  Fig. 1 Mean improvement from baseline in Genzyme 6-point grading scale score based on assessments by evaluating experts (*p≤0.05). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

• 

  Fig. 2 Proportion of subjects who showed great improvement (≥2 reduction of Genzyme 6-point grading scale score). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

• 

  Fig. 3 Mean GAIS score at 4 weeks and 12 weeks after treatment (*p≤0.05). HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden), GAIS: global aesthetic improvement scale.

• 

  Fig. 4 Subject (61 years/female) with dermal injection of HA-P in right nasolabial fold (NLF) and HA-G in left NLF. Genzyme 6-point grading scale change from baseline to 24 weeks. Right: HA-P, 3.6 to 2.3; left: HA-G, 3.3 to 0.3. (A) Baseline, (B) 4 weeks, (C) 12 weeks, and (D) 24 weeks after treatment. HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

• 

  Fig. 5 Subject (42 years/female) with dermal injection of HA-G in right nasolabial fold (NLF) and HA-P in left NLF. Genzyme 6-point grading scale changed from baseline to 24 weeks. Right: HA-G, 3.6 to 0.3; left: HA-P, 3 to 0.6. (A) Baseline, (B) 4 weeks, (C) 12 weeks, and (D) 24 weeks after treatment. HA: hyaluronic acid, HA-G, Glytone 3® (Merz Pharmaceuticals GmbH, Frankfurt, Germany); HA-P, Perlane® (Q-Med AB, Uppsala, Sweden).

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