A Real-World Evaluation of Definisse Filler for Facial Rejuvenation in Indian Patients: The REDEFINE REJUVENATION Study

TL;DR

This study evaluated the safety and effectiveness of Definisse filler for facial rejuvenation in Indian patients, finding it to be clinically effective with a positive safety profile.

Contribution

The study provides real-world data on Definisse filler's performance in Indian patients, a population for which prior evidence was lacking.

Findings

About 90% of patients showed significant improvement in appearance based on physician and self-assessment scales.

Most adverse events were mild and resolved on their own within a few days.

Improvement scores increased further during follow-up, indicating sustained results.

Abstract

Background and objective

India’s burgeoning aesthetic medicine sector has witnessed exponential growth, driven by increasing disposable incomes, social media influence, and a growing acceptance of cosmetic procedures. The approval of the first hyaluronic acid (HA) filler in 2003 initiated a wave of innovation; advancements in cross-linking and formulation now allow for tailored treatments across diverse patient needs and anatomical regions. The most recent addition to HA fillers, Definisse filler (RELIFE S.r.l., Florence, Italy) has gained attention specifically due to its proprietary manufacturing process, known as the eXcellent Three-Dimensional Reticulation (XTR) technology. However, it lacks robust real-world data in the Indian context. Hence, this study aimed to evaluate the safety and efficacy of Definisse fillers in a real-world setting among Indian patients.

Methodology

This was a multicenter, retrospective observational study that evaluated Indian adult patients who received facial rejuvenation treatments using the Definisse filler range (Touch, Restore, and Core). The study analyzed real-world clinical data to assess treatment outcomes, including efficacy and safety profiles in a diverse patient population.

Results

The study included 304 patients, with a mean follow-up duration of 3.9 months and an average age of 41.0 years. An average of 4.4 ml of Definisse filler was administered per patient. Both the Physician and Subject Global Aesthetic Improvement Scales (PGAIS and SGAIS) demonstrated immediate post-treatment improvement, with mean scores of 3.9 and 3.87, respectively. Further enhancement was observed during follow-up visits, with mean scores increasing to 4.37 and 4.33, respectively (p < 0.001 for both). Overall, about 90% of patients exhibited either 'much improvement' or 'very much improvement' on PGAIS at the follow-up visit. Most procedure-related adverse events were mild and resolved spontaneously within a few days without the need for active intervention.

Conclusions

The findings of this multicenter, real-world study indicate that Definisse fillers are clinically effective and exhibit a positive safety profile for facial rejuvenation in Indian patients. While these results show consistent clinical improvement, it must be noted that the study was designed as observational and retrospective and had a short mean follow-up. These findings provide valuable guidance for initial clinical practice, and further prospective studies are warranted to confirm long-term outcomes.

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