Effectiveness and safety of Lumina in treatment of nasolabial folds v2
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina™ in the Treatment of Nasolabial Folds
IRAS ID
297488
Contact name
Adam Gridley
Contact email
Sponsor organisation
LifeSprout, Inc.
Clinicaltrials.gov Identifier
2020-004218-37, EudraCT Number; NCT04839484, NCT number
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of LUMINA for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (NLFs; the line between the nose and the sides of the mouth). Eligible subjects 21 or older will be randomized to receive treatment with LUMINA in one nasolabial fold and a control in the opposite NLF. The control is a marketed dermal filler, Restylane Defyne.
Subjects will initially be treated and take home a diary. Subjects have an optional touch-up with same dermal fillers at 3 weeks where diaries will be turned in (and another taken if an optional touch-up injection occurs). Then follow-up visits will occur at week 6, and months 3, 6, 9, 12, where wrinkles will be visually assessed, photographs taken, questionnaires answered, and an eye examination will be done (this exam involves reading an eye chart and checking peripheral vision). At 12 months the subject can choose to have a retreatment in one or both folds with LUMINA. If no retreatment is done, the study is complete; if a retreatment occurs, the subject will return in an additional month and keep a diary during this time.
Primary effectiveness will be assessed at 6 months using the Wrinkle Severity Rating Scale. All subjects will be followed for a minimum of 12 months after the initial treatment. Two to ten sites in the UK and Europe will participate. Safety will be evaluated using a take home subject diary and physician assessment during visits.REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0363
Date of REC Opinion
15 Sep 2021
REC opinion
Further Information Favourable Opinion