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Hyaluronic acid gel that can be injected for use in augmenting soft tissues. An examination of the clinical and histopathological aspects
F Duranti 1 , G Salti, B Bovani, M Calandra, M L Rosati Affiliations

PMID: 9865196 DOI: 10.1111/j.1524-4725.1998.tb00007.x


Background information: Although there are a few different biomaterials that can be used for the goal of soft tissue augmentation, none of them have all of the characteristics that should be present in an ideal filler material. The relatively recent invention of hyaluronic acid gels for dermal implantation has opened up new options for efficient therapy in this field for medical professionals.

The purpose of this investigation is to conduct a clinical and histological evaluation of the safety and efficacy of a cross-linked stabilized non-animal hyaluronic acid gel (Restylane, Q-Med, Uppsala, Sweden) in order to determine the gel’s characteristics, advantages, disadvantages, and side-effects.

Methods: A facial intradermal implant of hyaluronic acid gel was used to treat 158 individuals for augmentation therapy of wrinkles and folds, as well as for lip augmentation and/or recontouring. At time 0 as well as at 1, 2, 4, and 8 months after the treatment, the results were examined in every patient using a combination of subjective evaluation by the treating physician and the patient themselves as well as photographic analysis. In addition, a more limited histology investigation was conducted on five healthy human volunteers for a period of fifty-two weeks to determine the interaction between the substance and human healthy skin as well as the duration of its effects.

Results: Clinically, both the physicians’ and patients’ evaluations demonstrated very good results, with a worldwide 78.5% and 73.4% respectively of moderate or substantial improvement after eight months, independent of the treated area. This improvement was seen in both the patients and the physicians. After eight months, the photographic exam revealed even more encouraging outcomes, with 80.4% of patients showing moderate or substantial improvement. According to the results of the safety evaluation, there were 12.5% of postoperative cases of immediate adverse effects, all of which were localized and temporary. There was no evidence of significant adverse effects on the systemic level. The product was demonstrated to be long-lasting and well tolerated by histology procedures, which were used to evaluate the product’s effectiveness.

In conclusion, stabilized hyaluronic acid gel that is not derived from animals is safe to use and effective in the treatment of augmentation therapy for soft tissues of the face. This substance offers a number of benefits in comparison to the injectable biomaterials that have been utilized in the past, and it broadens the range of therapeutic tools that are available in the field of soft tissue augmentation.


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