Addition of phenylephrine to JUVÉDERM® VOLIFT® with lidocaine.
Research type
Research Study
Full title
A multicenter, double-blind, randomized, within-subject controlled, study of the safety and performance of adding phenylephrine to JUVÉDERM® VOLIFT® with Lidocaine Injectable Gel for correction of moderate to severe nasolabial folds.
IRAS ID
142492
Contact name
Jonquille Chantrey
Contact email
Sponsor organisation
Allergan Ltd
Research summary
The objective of this study is to evaluate the safety and performance of JUVÉDERM® VOLIFT® with Lidocaine containing phenylephrine (S17L Vaso) compared to JUVÉDERM® VOLIFT® with Lidocaine (without phenylephrine; S17L) with respect to differences in vasoconstriction at the injection site assessed as injection site bruising following correction of moderate to severe nasolabial folds (NLFs).
This is a preapproval phase that consists of a randomised (treatment will be allocated by chance), double-blind (neither the researcher or patient will know which dose is administered), subject controlled study. Participants will be asked to take part in this study for a total of approx 1 month. The study plan includes up to 11 visits and 1 treatment procedure.
Participants will be assigned randomly to be treated with one of four treatment arms:
1)S17L in both NLFs
2)S17L in one NLF and S17L-vaso with 300ppm phenylepherine in the other NLF
3)S17L in one NLF and S17L-vaso with 400ppm phenylepherine in the other NLF
4)S17L-Vaso with 400ppm phenylepherine in both NLFs
The chance of getting any one of the arms is 25% (1 in 4 chance).
Male or female participants aged over 18 years old seeking correction of moderate to severe NLFs will be enrolled if they meet the eligibility criteria.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0855
Date of REC Opinion
11 Feb 2014
REC opinion
Further Information Favourable Opinion