CLIN LIF-001 Study
Research type
Research Study
Full title
A SPLIT-FACE COMPARISON OF TWO NEW HYALURONIC ACID DERMAL FILLERS versus REFERENCE HYALURONIC ACID DERMAL FILLERS IN THE TREATMENT OF MODERATE AND SEVERE NASOLABIAL FOLDS
IRAS ID
162202
Contact name
Chantal BELIN
Contact email
Sponsor organisation
Laboratoire SYMATESE
Research summary
This trial is an international phase II study, multicentre, randomized, evaluator-blinded, intra-individual comparison study, comprising 3-month treatment phase, followed by a 9-month extension phase.
The aim of the present study is to compare the efficacy and the safety of the two HA fillers manufactured by Symatese, denoted as LIF2 and LIF3, with those of reference products, Juvederm® Ultra 3 and Perlane-L®, in the treatment of moderate and severe NLFs, respectively.
At Day 0 visit, the treating investigator will inject the HA fillers according to the WSRS score:
• If the baseline WSRS score at the inclusion visit is equal to 3 i.e. moderate (Group A): the subject will receive injection of LIF 2 and Juvederm® Ultra 3 on the contralateral sides of the face.
• If the baseline WSRS score at the inclusion visit is equal to 4 i.e. severe (Group B): the subject will receive injection of LIF 3 on a NLF and Perlane-L® on the contralateral sides of the face.
During the primary period (3-month treatment phase), the subject will be seen at 4 or 5 scheduled visits (depends if the initial HA injection is done on the first or on the second visit). The response to the initial injection will be done after 2 weeks by the treating investigator. If the cosmetic result is judged to be suboptimal, touch-up could be performed after subject’s approval with the same filler material until an optimal cosmetic result is achieved. Two follow-up visits will be done at 1 month and 3 months after the last injection.
During the extended follow-up phase (9-month extension phase), subject will be subsequently seen at regular intervals for follow-up visits at 6, 9 and 12 months after the last injection (initial or touch-up, if performed).
If the subject returned to baseline at Month 12 visit, he could receive an optional, complementary repeat injection with the same LIF products during this visit. In this case, a phone call 72 hours after the repeat injection and subsequent visits will be done: 14 days and 6 months after the repeat injection to check safety of treatment.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/1201
Date of REC Opinion
5 Jan 2015
REC opinion
Further Information Favourable Opinion