Randomized Double-Blind Controlled Study on the Safety and Efficacy of a Novel Injectable Cross-linked Hyaluronic Gel for the Correction of Moderate-to-Severe Nasolabial Wrinkles
| Autor: | Francesca Romana Grippaudo, Nicolò Scuderi, Marco Toscani, Nicola Giordan, Pasquale Fino |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Nasolabial Fold Erythema fillers Dentistry skin wrinkles Cosmetic Techniques 030230 surgery law.invention Injections 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method Rating scale law Dermal Fillers Medicine Humans Hyaluronic Acid Adverse effect Wrinkle Balance (ability) esthetic surgery business.industry Middle Aged Skin Aging Treatment Outcome Otorhinolaryngology Itching Surgery Female medicine.symptom business Gels |
| Zdroj: | Aesthetic plastic surgery. 43(2) |
| ISSN: | 1432-5241 |
| Popis: | The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles. This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness. Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student’s t test: p = 0.2181). No significant differences were observed with regard to the subject’s satisfaction and adverse events. The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . |
| Databáze: | OpenAIRE |
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