Evaluating Safety and Effectiveness of Dr. Korman Laboratories Hyaluronic Acid and Lidocaine Dermal Filler for Lip Enhancement in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of a dermal filler called DKL crosslinked hyaluronic acid 20 mgmL with lidocaine 0.3% for lip augmentation in healthy men and women who have thin lips and desire fuller lips. This single-arm, open-label study involves participants acting as their own control to assess the improvement in lip appearance over time. Participants will receive injections of the DKL crosslinked sodium hyaluronate 20 mgmL with lidocaine 0.3% dermal filler into both their upper and lower lips. The study focuses on lip augmentation using this injectable sterile gel. The treatments effect will be evaluated at multiple time points up to 48 weeks after the initial injection. Assessments include pain during injection, aesthetic improvements, and device usability. During the study, participants will undergo evaluations of lip fullness using the Lip Fullness Grading Scale and aesthetic improvements rated by both investigators and subjects. Other assessments include lip function, sensation, texture, and satisfaction with the lips and overall outcome. Participants will keep diaries to track post-treatment events and adverse effects. The study lasts up to 48 weeks, with multiple follow-up visits to monitor safety and effectiveness of the filler.

A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation