Study to Evaluate the Safety and Effectiveness of GP0116

Condition(s) studied

Investigational drug(s) / intervention(s)

GP0116: GP0116 is an injectable, sterile, transparent product.

Active Comparator: FDA approved dermal filler device (RHA 3): FDA approved dermal filler device (RHA 3)

Study summary

This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).

Eligibility

Primary outcome measure(s)

• To demonstrate non-inferiority of GP0116 versus a comparator control — At 3 months after Baseline
  To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).

Trial sites (19)

More Galderma R&D trials in the USA