Phase 4
N=185
Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines
Glabellar Rhytides
Bottom Line
View on ClinicalTrials.gov: NCT01814670 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction — 97.1 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- botulinum toxin Type A (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction |
97.1; 90.2; 81.5 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction |
97.1; 90.2; 81.5 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction |
90.1; 93.1; 81.5; 72.3 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest |
62.7; 65.7; 65.7; 62.7 | — |
| SECONDARY Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest |
59.9; 58.4; 50.9; 49.1 | — |
Summary
A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.
Eligibility Criteria
Inclusion Criteria
- moderate or severe frown lines
- facial laser treatment between 4 to 8 weeks prior to Day 1
Exclusion Criteria
- previous use of botulinum toxin for any indication
- diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
- facial cosmetic procedures within the last 6 Months
- treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
- use of a new topical skin care product within 1 month of the screening
- any prior forehead or periorbital surgery or brow lift
- deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
- any facial skin infection or unhealed skin lesion
- pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01814670). 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.