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GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA

A Journal on Dermatology and Sexually Transmitted Diseases


Official Journal of the Italian Society of Dermatology and Sexually Transmitted Diseases
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Giornale Italiano di Dermatologia e Venereologia 2001 August;136(4):293-301

language: Italian

Efficacy and tolerability Italian multicentric study of non-animal hyaluronic acid (Restylane®) for the treatment of facial aesthetic disorders: evaluation of 348 cases

Distante F. 1, Bandiera A. 2, Bellini R. 3, Bizzarri S. 4, Bonanni G. 5, Borda G. 6, Cencetti R. M. 7, Chiroli A. 8, D’Alessandro V. 9, Di Cugno I. 10, Franchini D. 11, Lacoppola G. 12, Fedele Larrone M. 13, Leone M. S. 14, Lovreglio R. 15, Mazzarella F. 16, Pelliccia R. 17, Simoni A. 18, Simoni L. 19, Valeriani M. 20

1 Specialista in Dermatologia e Venereologia, Nuova ICT Srl - Codogno (Lodi)
2 Specialista in Dermatologia e Venereologia - Bari
3 Specialista in Chirurgia d’Urgenza - Bologna
4 Medico Chirurgo - Roma
5 Specialista in Medicina del Lavoro - Roma
6 Specialista in Dermatologia e Venereologia - Bologna
7 Specialista in Dermatologia e Venereologia - Genova
8 Medico Chirurgo - Forte dei Marmi (Lucca)
9 Medico Chirurgo - Bari
10 Medico Chirurgo - Trani (Bari)
11 Specialista in Dermatologia e Venereologia - Rutigliano (Bari)
12 Medico Chirurgo - Pisa
13 Specialista in Dermatologia e Venereologia - Gravina (Bari)
14 Specialista in Chirurgia Plastica e Ricostruttiva - Genova
15 Specialista in Dermatologia e Venereologia - Bari
16 Specialista in Dermatologia e Venereologia - Bari
17 Medico Chirurgo - Roma
18 Specialista in Dermatologia e Venereologia - Bari
19 Specialista in Dermatologia e Venereologia - Bari
20 Specialista in Chirurgia Plastica e Chirurgia Vascolare - Roma


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Background. In the last few years the development of injectable stabilized gels for dermal implantation has induced a great interest among scientists involved in the field of aesthetic medicine. This is probably due to the unique properties of efficacy and safety shown by such material, in particular to its facility of use and biological compatibility. However, such unique characteristics have been poorly documented in literature until now. The aim of the study was to evaluate the aesthetic results and the tolerability in subjects treated with a stabilized non-animal hyaluronic acid gel (Restylane®, Q-Med, Uppsala, Sweden).
Methods. Three hundred and forty-eight subjects treated with injectable hyaluronic acid for soft tissue augmentation were enrolled in the study. At fixed interval times during 10 months after treatment, a clinical evaluation of efficacy and tolerability was performed. The clinical evaluation was based on a semiquantitative scale ranging from 0 (= none) to 10 (maximum). At the end of the study an overall assessment on the treatment and the material was performed (scale 0-10).
Results. Efficacy assessment shows a high correction level at the treated sites immediately after treatment (mean value = 8,9). No statistically significant change of the initial correction level is observed until the control performed after 6 months. After 6 and 10 months the reported efficacy evaluation is significantly decreased by 41 and 60%, respectively, compared to the initial evaluation. The reported adverse events were judged as mild-moderate and transient, therefore they did not influence the tolerability evaluation values, that remain high at all the control times of the follow-up.
Conclusions. The results of the study confirm that the stabilized non-animal hyaluronic acid is well tolerated and effective for soft tissue augmentation.

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