Phase 4
Completed N=14
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Forehead Rhytides · Forehead Wrinkles
Source: ClinicalTrials.gov NCT03799484 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Eyebrow Excursion — 10.57; 10.57 millimeters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eyebrow Excursion |
8.21; 8.07 | — |
| SECONDARY Duration of Botulinum Toxin Type A Effect |
14.2857; 15.2857 | — |
| SECONDARY Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale |
2.43; 3.96 | — |
| SECONDARY Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey |
8; 2; 1; 3; 0 | — |
| SECONDARY Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey |
8; 2; 1; 3; 0 | — |
| SECONDARY Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey |
8; 2; 1; 3; 0 | — |
| SECONDARY Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face |
— | — |
Eligibility Criteria
Inclusion Criteria
- 18 to 65 years of age
- Presence of horizontal forehead rhytides
- Good eyebrow excursion (greater than or equal to 5 mm)
- Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects
Exclusion Criteria
- Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
- Known allergy to botulinum toxin
- Known history of sensitivity to local anesthetics of the amide type
- Existing disorder of neuromuscular transmission
- Usage of medication with effect on neuromuscular function
- Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
- Significant brow asymmetry (> 5mm)
- Unable to follow-up for the duration of the study (16 weeks)
Data sourced from ClinicalTrials.gov (NCT03799484). 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. Informational only — not medical advice.