A Randomized, Evaluator-Blinded, Controlled Study of the Effectiveness and Safety of Small Gel Particle Hyaluronic Acid for Lip Augmentation

被引：41

作者：

Glogau, Richard G. ^{[1
]}

Bank, David ^{[2
]}

Brandt, Fredric ^{[3
]}

Cox, Sue Ellen ^{[4
]}

Donofrio, Lisa ^{[5
]}

Dover, Jeffrey ^{[6
]}

Grekin, Steven ^{[7
]}

Lawrence, Ira ^{[8
]}

Lin, Xiaoming ^{[8
]}

Nestor, Mark ^{[9
,10
]}

Shamban, Ava ^{[11
]}

Stewart, Daniel ^{[12
]}

Weiss, Robert ^{[13
]}

Axford-Gatley, Robert A. ^{[14
]}

Theisen, Michael J. ^{[14
]}

Smith, Stacy ^{[15
]}

机构：

[1] Richard G Glogau Inc, San Francisco, CA USA

[2] Ctr Dermatol Cosmet & Laser Surg, Mt Kisco, NY USA

[3] Dermatol Res Inst LLC, Coral Gables, FL USA

[4] Aesthet Solut, Chapel Hill, NC USA

[5] Savin Ctr, New Haven, CT USA

[6] SkinCare Phys, Chestnut Hill, MA USA

[7] Grekin Skin Inst, Warren, MI USA

[8] Medicis Aesthet, Scottsdale, AZ USA

[9] Ctr Clin & Cosmet Res, Aventura, FL USA

[10] Univ Miami, Miller Sch Med, Dept Dermatol, Miami, FL 33136 USA

[11] Ava T Shamban Inc, Santa Monica, CA USA

[12] Michigan Ctr Skin Care Res, Clinton Township, MI USA

[13] Maryland Laser Skin & Vein Inst, Hunt Valley, MD USA

[14] Complete Healthcare Commun Inc, Chadds Ford, PA USA

[15] Dermatol & Consulting, Cardiff By The Sea, CA USA

来源：

DERMATOLOGIC SURGERY | 2012年 / 38卷 / 07期

关键词：

FILLERS; FULLNESS;

D O I：

10.1111/j.1524-4725.2012.02473.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100227 [皮肤病学];

摘要：

Objectives To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation. Methods Adults (n=180; aged 1865) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (=1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study. Results Statistically significantly more MLFS responders (=1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p<.001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p<.001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events. Conclusions SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8weeks, with visible results reported in the majority of participants 6months after treatment.

引用

页码：1180 / 1192

页数：13

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