NCT07204691

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

A SINGLE-ARM, OPEN-LABEL CLINICAL INVESTIGATION TO EVALUATE THE SAFETY AND PERFORMANCE OF DKL CROSSLINKED SODIUM HYALURONATE 20 MG/ML +LIDOCAINE 0.3% DERMAL FILLER FOR LIP AUGMENTATION

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Dr. Korman Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and effectiveness of a dermal filler called DKL crosslinked hyaluronic acid 20 mg/mL with lidocaine 0.3% when injected into the lips of healthy men and women who want to have fuller lips. The change in the appearance of the lips will be checked.

Detailed description

This is a single-arm, open-label, multi-center clinical investigation to evaluate the safety, performance, and usability of DKL crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% for lip augmentation in healthy male and female volunteers with thin lips. Eligible participants will undergo treatment with crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% injected into the lips for lip augmentation. Each participant will act as his/her own control. The improvement in lip appearance over time will be evaluated.

Conditions

• Lip Augmentation

Interventions

Type	Name	Description
DEVICE	DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler	DKL crosslinked sodium hyaluronate 20 mg/mL + lidocaine 0.3% dermal filler is an injectable sterile, non-pyrogenic gel composed of crosslinked sodium hyaluronate of a non-animal origin and lidocaine in a phosphate-buffered saline solution.

Timeline

• Start date: 2025-09-24
• Primary completion: 2026-03-01
• Completion: 2027-03-01
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

2 sites across 1 country: Sweden