N/A
N=143
Evaluation of Four Injectable Neuromodulators in the Glabella Area Glabella Area
Cosmetic Techniques
Bottom Line
View on ClinicalTrials.gov: NCT05167864 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: the Change in Dynamic Strain in the Glabella Area After Injection Over Time — 6.4; 10.9; 6.6; 8.9 percent difference of neutral+dyanamic
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Onabotulinumtoxina for Injection (Drug); Abobotulinumtoxina for Injection (Drug); IncobotulinumtoxinA for Injection (Drug); PrabotulinumtoxinA for Injection (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Change in Dynamic Strain in the Glabella Area After Injection Over Time |
6.4; 10.9; 6.6; 8.9; 8.6; 10.6 | — |
| SECONDARY Correlation Patient Reported Satisfaction (FACE-Q) to the Degree of Dynamic Strain Overtime |
-0.0870; -0.013; 0.049; -0.095; 0.033; -0.018 | 0.13519 |
Summary
The purpose of the study is to use 3D imaging to evaluate the effects of four FDA approved neuromodulators on facial lines, wrinkles and animation. Participation is available to women who have never had a cosmetic procedure above the malar region nor a treatment with a neuromodulator within 12 months. All subjects will undergo 3D imaging using the VECTRA M3 (Canfield Scientific, Inc, Fairfield, NJ) prior to treatment with a neuromodulator in order to determine their baseline dimensions. Imaging will be repeated post injection to determine change over time.
Eligibility Criteria
Inclusion Criteria
- Female
- 30-65 years of age
- Interested in glabellar injections to reduce rhytids and facial strain
- Participants must sign the informed consent form
Exclusion Criteria
- Females under 30 or above 65 years of age
- Males
- Those who have received glabellar injections for rhytids <12 months
- Underwent cosmetic surgical procedure above the malar region
- Those with a condition that affects facial expression, such as prior stroke
Data sourced from ClinicalTrials.gov (NCT05167864). 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.