60
Participants
Start Date
September 30, 2025
Primary Completion Date
May 31, 2026
Study Completion Date
November 30, 2026
(Bridging) Horizontal Cannula Technique for Treatment of Nasolabial Folds using AILEENE Vol. 2
Participants will receive treatment to both NLF using the Bridging Technique. This involves injecting an HA dermal filler (AILEENE Vol. 2) in thin horizontal threads (less than 0.05 milliliters \[ml\] per retrograde placement) under the fold using a blunt cannula. The maximum total dose per participant is 1.0 ml across both folds. Each participant will receive one treatment at baseline (Day 0). An optional single top-up may be given at Week 2 (virtual or in-clinic) or Week 4 if clinically indicated, using only the remaining balance of the 1.0 ml total. Any top-up will be performed with a new, sterile syringe, not with filler left over from the initial treatment. This is a single-treatment course with follow-up for 6 months. Standardized photographs will be taken at Baseline, Week 4, Month 3, and Month 6 for blinded assessment.
Cg Bio Co., Ltd.
INDUSTRY
Dr. Joseph M Novoa Libermann
OTHER