Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines
Summary
The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines \[UFL\]): Horizontal Forehead Lines \[HFL\], Glabellar Frown Lines \[GFL\], and Lateral Canthal Lines \[LCL\]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.
Timeline
- Start
- 2020-09-23
- Primary completion
- 2021-04-15
- Completion
- 2022-05-09
Outcome
Met primary endpoint
registry NUMBER Main Period: Placebo (Group P): 0 percentage of subjects NCT04594213 ↗
registry NUMBER Main Period: NT 201 (Group U): 52.3 percentage of subjects NCT04594213 ↗
registry analysis (superiority test); Main Period: Placebo (Group P) vs Main Period: NT 201 (Group U); p <0.0001; Mantel Haenszel NCT04594213 ↗
registry NUMBER Main Period: NT 201 (Group U): 66.5 percentage of subjects NCT04594213 ↗
registry NUMBER Main Period: NT 201 (Group U): 51.7 percentage of subjects NCT04594213 ↗
paper In both studies, incobotulinumtoxinA treatment was significantly more effective than placebo with respect to the primary endpoints (P < .0001) PMID 39475143 ↗
Publications
- Pavicic T, Burgess C, Fabi S, Nestor MS, Bee EK, Imhof M, Dersch H, Sudimac V. Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines. J Cosmet Dermatol. 2025 Sep;24(9):e70460. doi: 10.1111/jocd.70460.
- Joseph J, Sudimac V, Mersmann S, Kerscher M. IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From Two Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. Aesthet Surg J. 2025 Feb 18;45(3):293-304. doi: 10.1093/asj/sjae222.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 40 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 64 iu | Intramuscular |
Indications
No indication recorded.