Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study

Ascher, Benjamin; Bayerl, Christiane; Brun, P.; Kestemont, Philippe; Rzany, Berthold; Poncet, Michel; Guennoun, Mohammed; Podda, Maurizio

doi:10.1111/j.1473-2165.2011.00550.x

Cited by 48 publications

(38 citation statements)

References 13 publications

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“…Similar to previously reported interim data, 7 HA ED was noninferior to HA PER in terms of mean change from baseline in WSRS score at 6 months after the baseline treatment. At this time point, the mean between-treatment difference (HA PER − HA ED ) was 0.24, and the 95% CI ranged between 0.10 and 0.37 (i.e., above the predetermined margin [−0.5]).…”

Section: Resultssupporting

confidence: 89%

“…7 Here, the final effectiveness and safety outcomes up to 12 months after the baseline treatment were reported, thereby extending the published literature on product duration and safety for HA ED in comparison with a well-established HA filler (HA PER ) that has a similar intended use. This is also the first long-term study of HA ED , and the first long-term comparison of these two products for the treatment of severe NLFs.…”

mentioning

confidence: 62%

“…The final effectiveness results reported here are similar to the interim results reported previously. 7 …”

Section: Discussionmentioning

confidence: 99%

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A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

Ascher¹,

Bayerl²,

Kestemont³

et al. 2017

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BACKGROUNDHyaluronic acid (HA) filler injection is an increasingly popular aesthetic procedure.OBJECTIVETo compare the effectiveness and safety of two HA fillers (HAED and HAPER) for the treatment of severe nasolabial folds (NLFs).MATERIALS AND METHODSThis was an evaluator-blinded and subject-blinded split-face study. At baseline, HAED or HAPER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment.RESULTSAt 6 months, HAED was noninferior to HAPER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HAED at 3 to 12 months, and a majority of subjects preferred HAED over HAPER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. At 12 months, approximately 80% of subjects were still responders. Both products were well tolerated and associated with a few treatment-related adverse events.CONCLUSIONTo conclude, HAED was at least as effective and well tolerated for the treatment of severe NLFs as HAPER.

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Section: Resultssupporting

confidence: 89%

mentioning

confidence: 62%

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A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

Ascher¹,

Bayerl²,

Kestemont³

et al. 2017

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“…The authors have concluded that, in addition to subjective assessment methods, a quantitative analysis is recommended using more objective methods to minimize the interrater variability [20]. In a recent study, Shin et al [2] and Asher et al [6] reported subjective assessment by blinded investigators of the efficacy of a dextran filler and different forms of hyaluronic acid on the correction of nasolabial folds. Finally, Brandt and collaborators have used the WSRS to assess facial wrinkles treated with hyaluronic acid but they have not specified if the evaluators were blinded [5].…”

Section: Wrinkle Severity Rating Scale (Wsrs)mentioning

confidence: 98%

Assessment Tools for Facial Rejuvenation Treatment: A Review

et al. 2016

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“…Mild injection site reactions Treatment related [76] Prospective study (n = 60), 6 months follow-up ‡ Short term complications erythema, edema/swelling, bruising, pruritus, pain, tenderness Treatment related [77] Prospective study (n = ? ), 6 months follow-up…”

Section: Hyaluronic Acid (Cross-linked)mentioning

confidence: 99%

Clinical data on injectable tissue fillers: a review

Vries

Geertsma

2013

Expert Review of Medical Devices

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Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications. . Moreover, it is expected that due to increase in life expectancy, the demand for anti-aging treatments, like tissue augmentation with injectable tissue fillers, will grow [2]. Their success has been attributed to the fact that treatments with injectable tissue fillers are fast and appear to be relatively easy [2]. Only a relatively 'simple' subcutaneous injection is needed. Today, various injectable tissue fillers with different characteristics are available, for example, duration of the effect, material type and intended anatomical location.Although the application of an injectable tissue filler seems to be relatively simple and safe, reports of serious adverse effects have appeared in the literature [2][3][4][5][6][7][8]. Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients [9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) [11,12]. Short-, mid-and long-term complications can be discerned (TABLE 1) [2,13-15]. Short-term complications like pain, swelling, fever, immediate hypersensitivity reactions, occur immediately or within several days past treatment and disappear after several weeks. A more severe short-term complication is necrosis [5,16]. Necrosis occurs immediately or within a few days if blood vessels are obstructed by the filler material or if they are injured during the treatment [17]. Mid-term complications such as delayed inflammatory reactions, ulceration and granuloma reaction may occur after 2-12 months. I...

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Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, evaluator-blinded, intra-individual comparison study

Abstract: The new HA filler HA(E) provides better efficacy and similar local tolerability compared with HA(P) 6 months after the treatment of severe NLF.

Cited by 48 publications

References 13 publications

A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

Assessment Tools for Facial Rejuvenation Treatment: A Review

Clinical data on injectable tissue fillers: a review

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