In the two primary U.S. clinical studies evaluating Juvederm Ultra or Juvederm Ultra Plus for safety and effectiveness, roughly 145 subjects were followed for 24 weeks after the Juvederm injection in one nasolabial fold.
Compared to Zyplast dermal filler (bovine-based collagen) which was injected into the opposite nasolabial fold, Juvederm injection site reactions were similar in duration and frequency, mild to moderate in severity, did not require intervention, and typically lasted about 7 days.
Redness, pain/tenderness, firmness, swelling and lumps/bumps occurred in roughly 80-90% of patients, bruising in 60% of patients, and itching and discoloration in roughly 35% of patients.
The percent of patients who maintained improvement with Juvederm at 24 weeks was 88-90% compared to 36-40% with Zyplast.
At study end, 84-88% of the patients expressed a preference for Juvederm Ultra injectable gel, 5-10% had a preference for Zyplast, and 5-6% of patients had no preference.
Of 146 subjects, 111-116 (76-79%) returned for a complimentary repeat treatment at an average of 36 weeks after their last injection. Forty-eight subjects returned after 36 weeks.
Subjects who maintained improvement with Juvederm Ultra injectable gel was 75-81%.
Patients rated their improvement prior to injection as mainly mild to moderate (between 1 and 2 on a scale going from 0 [no improvement] to 4 [extreme improvement]) from 2 weeks until greater than 36 weeks after injection.