A Randomized, Split-Body, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Poly-l-lactic Acid for the Treatment of Upper Knee Skin Laxity

Abstract

BACKGROUND Skin laxity of the upper knee and lower thigh is a common complaint among patients. OBJECTIVE This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-l-lactic acid (PLLA) for treatment of upper knee skin laxity. MATERIALS AND METHODS Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water. RESULTS Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale. CONCLUSION Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.

Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA)

“…Few minimally invasive options have been published like lipofilling, 115 microfocused ultrasound, 116 and more recently, collagen-stimulators such as CaHA 10 , 117 and PLLA. 98 , 118 , 119 …”

“…PLLA to correct skin laxity of the knees was assessed in three recent studies using different techniques and reported to lead to an improvement of skin laxity and a significant increase of skin thickness associated with a favorable safety profile ( Table 4 ). 98 , 118 , 119 They concerned few cases treated for this condition 98 , 118 although, interestingly a very recent randomized, double-blind, split-body placebo-controlled study was performed on 20 patients with mild-to-severe skin laxity, treated at the anterior upper knees. 119 The results showed a statistically significant improvement versus placebo on the primary endpoint, the PGAIS (Physician Global Aesthetic Improvement Scale) from 28 days to 168 days after 3 treatment sessions (1 vial/session; 16mL/vial).…”

“… 98 , 118 , 119 They concerned few cases treated for this condition 98 , 118 although, interestingly a very recent randomized, double-blind, split-body placebo-controlled study was performed on 20 patients with mild-to-severe skin laxity, treated at the anterior upper knees. 119 The results showed a statistically significant improvement versus placebo on the primary endpoint, the PGAIS (Physician Global Aesthetic Improvement Scale) from 28 days to 168 days after 3 treatment sessions (1 vial/session; 16mL/vial). The safety profile was favorable with only minor adverse events reported.…”

Evaluation of Cannula Safety in Injection of Poly-L-Lactic Acid

“…Poly-L–lactic acid (PLLA) in the form of Sculptra ® Aesthetic™ (Galderma Laboratories, L.P.) is used to increase the volume of depressed areas in the face and various body regions (eg, neck, decolletage, breasts, arms, hands, abdomen, thighs, knees, glutes). 1–7 The United States Food and Drug Administration approved PLLA in 2004 for the treatment of facial lipoatrophy and in 2009, for the indication of volume loss; 8 , 9 although it has been used in various medical applications for longer than three decades (eg, surgical stents and implants). 8 , 10 The mechanism of action of PLLA operates mainly through generating a foreign-body reaction.…”

“… 11 , 12 The resulting effect is a decrease in skin laxity and improvement in anatomical contours. 1 , 13 , 14 …”