Clinical information

Science has always been the driving force behind the Aquamid® products. Aquamid® is developed, tested and manufactured in compliance with the European Medical Devices Directive, and enjoys an unmatched track record of continuous high levels of patient satisfaction.

The efficacy and safety of Aquamid® have been documented in several clinical trials involving more than 5,000 patients. These studies have been published in peer-reviewed journals 1-10, 12-18. For more clinical information regarding Aquamid® please review the Aquamid® White Paper.

As with any filler, adverse events related to treatment were mostly mild transient local reactions. In rare cases, local infections have occurred and have been resolved with antibiotic treatment.

 

Microphoto of Aquamid® (see arrows) injected into the chin four years previously. It is surrounded by muscle fibres (MF), fat cells (FC) and connective tissue (CT). It is anchored by a fine network of host connective tissue strands (arrows).

Proven aesthetic satisfaction four years after injection

In a long-term prospective multicentre clinical trial with Aquamid®, investigators judged the aesthetic results at the 1-year, 2-year and 4-year follow-up as very good or good in more than 90% of the patients 11,15,16.  Furthermore, over 90% of patients were either very satisfied or satisfied at the 1-year, 2-year and 4-year follow-up. Data from the 5-year follow-up shows similar aesthetic results and patient satisfaction19.

Inject Aquamid® subcutaneously to replace lost volume that causes deeper wrinkles and facial folds. Aquamid® becomes a soft and stable part of the tissue, and years later, the effect remain, in natural harmony with the body.

For detailed information please refer to: Clinical bibliography

 

Aquamid® Reconstruction has a similar composition to Aquamid® but higher viscosity, making it particularly suitable for augmentations requiring larger volumes, such as the treatment of lipoatrophy.

LASTING TREATMENT FOR FACIAL LIPOATROPHY

Facial Lipoatrophy causes an erosion of self-esteem and decreasing social function of HIV positive patients receiving antiretroviral therapy 8,13. Aquamid®

Reconstruction is uniquely suited to replace lost tissue volume or add extra volume where needed, to recreate facial contours.

Aquamid® Reconstruction is especially designed for reconstructive corrections and has been approved for use in corrections of facial lipoatrophy, e.g. in HIV positive patients receiving antiretroviral therapy.

The safety and efficacy of Aquamid® injected in patients with Lipoatrophy has been documented 8,13. Aquamid® provides a minimally invasive, effective, long-lasting facial contour correction that significantly improves the quality of life in HIV positive patients receiving antiretroviral therapy 8.

Aquamid® restores self-confidence, removes stigmatization, and gives a natural look with no loss of mimic or scarring. Aquamid® has lasting psychological benefits and improves patients’ quality of life 10,18.

A 2-year clinical trial of patients with HIV related Lipoatrophy conducted at the University Hospital in Modena, Italy was recently published 8. The trial has documented with photographic and psychological assessment that the cosmetic results after Aquamid® treatment showed lasting improvement in self-esteem of the patients.The authors also noted improved tissue tolerance, durability and safety when using Aquamid® for facial contouring of the immuno-compromised patients.

Another trial conducted at the University Hospital in Barcelona, Spain evaluated the clinical efficacy of facial injections comparing Aquamid®, autologous fat and poly-lactic acid 13. The investigators concluded that Aquamid® provided the longest lasting effect since only 8% needed new injections versus 85% and 88% of those who received poly-lactic acid and autologous fat, respectively.