CLINICAL DATA

The different types of the ALAYNA product line show in more than 900 patients that treatment with all product types is clinically safe and significantly effective in correcting disease- or age-related volume loss or defects of the facial skin in the intended application. 

Post-marketing follow-up studies have confirmed these positive results. All final products have the same material composition, are derived from the same raw material and differ mainly in HA concentration.

ALAYNA SG products have proven clinical data from over 200 treatments, demonstrating significant efficacy and excellent long-term safety.

A 5-point scale was used to measure the degree of improvement from baseline immediately after treatment, 2-3 weeks after treatment, and 3, 6, and 12 months after treatment. Improvement of at least one scale point was maintained for 6 months, with no return to baseline even after 12 months.

Treatment with the ALAYNA SG 24 Distinct showed significant improvement from baseline even after 9 months (P value < 0.00001). All ALAYNA SG types resulted in treatments with responder rates of at least 75% at 6-7 months.

The safety of all ALAYNA SG products was excellent, with no product-related or serious adverse effects. No lumps, inflammation, nodules, or late reactions occurred. Only mild to moderate injection-related short-term adverse reactions occurred, lasting less than 3 days on average.

Patient and physician satisfaction was assessed using the Global Aesthetics Scale (GAIS) on a scale of -1 to 3. Immediately after treatment, both patients and physicians rated the appearance of the treated area as greatly to very greatly improved: 2.52 and 2.46, respectively.