Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EMLA · 1 trial · 1 indication
This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement. Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.
| Arm | Type | Description |
|---|---|---|
| DGE | EXPERIMENTAL | Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment period were treated with DGE as an open-label treatment. |
| Restylane | ACTIVE_COMPARATOR | Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. |
| Name | Type | Description |
|---|---|---|
| Dermal Gel Extra (DGE) | DEVICE | Dermal Gel Extra (DGE) Injectable Gel contains hyaluronic acid with lidocaine. DGE was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of DGE to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period. |
| Restylane | DEVICE | Restylane was administered to nasolabial folds via the intradermal route. The Principal Investigator was instructed to inject a sufficient amount of Restylane to ensure full correction of the NLF wrinkles (i.e., to the optimal level of correction achievable). Up to 2 touch-up treatments were allowed in the Initial Treatment period. |
| EMLA Cream | DRUG | EMLA Cream (Eutectic Mixture of Local Anesthetics) is an FDA-approved topical anesthetic comprised of 2.5% each of lidocaine/prilocaine. EMLA Cream was applied in approximately equal amounts prior to all injections of DGE and Restylane. |
Inclusion Criteria (abbreviated list): * Bilateral nasolabial folds (NLF) with severity score of 3 or 4 on the 6 point scale. Exclusion Criteria (abbreviated list): * Pregnant/lactating women. * Subjects who have an allergy to lidocaine, prilocaine or other amide-type anesthetic. * Had a chemical...
EMLA is a small molecule drug being studied for the treatment of facial wrinkles at the nasolabial folds. It is currently in Phase 3 clinical development as an investigational therapy for this aesthetic indication.
EMLA is being developed by Sanofi, a global biopharmaceutical company. Sanofi is publicly traded on the stock exchange under the ticker symbol SNY.
EMLA is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for the treatment of facial wrinkles at the nasolabial folds.
EMLA has one completed Phase 3 clinical trial, identified as NCT00444626. This study compared the safety and effectiveness of a non-FDA approved device, Dermal Gel Extra (DGE), with an FDA approved device for the correction of nasolabial folds. The trial enrolled 140 participants in the United States.
EMLA is not the same as Dermal Gel Extra (DGE). In the clinical trial NCT00444626, DGE was the investigational product being studied, while EMLA was not mentioned as an alternative name for it. The trial compared DGE to an FDA approved device for the correction of nasolabial folds.