Phase 4
N=50
Botox Cosmetic and the Young Patient With Glabellar Furrows
Glabellar Furrows
Bottom Line
View on ClinicalTrials.gov: NCT00856999 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Reduction of the Facial Wrinkle Scale — 1.86; 2.10 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botox (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Oregon Health and Science University
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of the Facial Wrinkle Scale |
1.86; 2.10 | <.001 sig |
| PRIMARY Patient Assessed Frown-line Improvement |
7; 24; 69 | <.0004 sig |
Summary
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox injections will be used to see if the effects of the Botox treatment last longer than the effects of the standard injection regimen.
Eligibility Criteria
Inclusion Criteria
- Female
- Fitzpatrick Skin Types I-III
- Between 30 and 50 years of age
- At least moderate severity at maximum frown
Exclusion Criteria
- Prior botulinum toxin treatment
- Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as aminoglycoside antibiotics) that might interfere with neuromuscular function
- Any other condition or situation that might put the subject at significant risk, confound the study results (such as significant pre-existing brow or eyelid ptosis)
- Allergy or sensitivity to any study component
- Participation in another clinical study within 30 days of the study start date
- Are planning other facial cosmetic procedures during the study period, or are pregnant, breastfeeding, or planning a pregnancy during the study.
Data sourced from ClinicalTrials.gov (NCT00856999). 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.