Phase 2
N=241
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
Moderate to Severe Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT03806933 ↗Enrolled (actual)
241
Serious AEs
0.4%
Results posted
Oct 2023
Primary outcome: Primary: Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS — 175; 185; 210; 215 days — p== 0.881
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NT 201 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merz Aesthetics GmbH
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS |
175; 185; 210; 215 | = 0.881 |
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
25; 23; 26; 22 | — |
| PRIMARY Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE) |
0; 0; 0; 1 | — |
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI) |
1; 0; 2; 2 | — |
| PRIMARY Number of Participants With at Least One Treatment Related TEAE |
7; 6; 8; 7 | — |
| PRIMARY Number of Participants With at Least One Treatment Related TESAE |
0; 0; 0; 0 | — |
| SECONDARY Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS |
113; 121; 129; 148 | — |
| SECONDARY Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS |
96; 118; 122; 145 | — |
| SECONDARY Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS |
8.2; 8.3; 16.4; 18.6 | — |
| SECONDARY Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS |
6.6; 10.0; 19.7; 16.9 | — |
| SECONDARY Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS |
32.8; 43.3; 52.5; 52.5 | — |
| SECONDARY Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS |
37.7; 36.7; 52.5; 45.8 | — |
Summary
The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).
Eligibility Criteria
Inclusion Criteria
- Male or female participant 18 years or over.
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.
Exclusion Criteria
- Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
- Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
- Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
- Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
- Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
- Any surgery or scars in the glabellar area.
- Marked facial asymmetry.
- Eyelid ptosis.
- Marked brow ptosis and/or dermatochalasis.
- Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
Data sourced from ClinicalTrials.gov (NCT03806933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.