Facial Fine Lines
Conditions
Keywords
Facial Fine Lines,BOTOX,Onabotulinum Toxin A
Brief summary
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
Interventions
DRUGBotox
Intradermal (ID) injection
DRUGPlacebo
Intradermal (ID) injection
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* A female participant must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study (eg, for at least 90 days after receiving study intervention). * Participant must have sufficient visual acuity without the use of eyeglasses (contact lans use acceptable) to accurately assess their facial lines, in the opinion of the investigator. * Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active COVID-19 infection. * Be nonsmoking and a nonuser of cannabis and nicotine-containing products, or have not smoked or used cannabis or nicotine-containing products, including e-cigarettes, within the previous 2 years.
Exclusion criteria
* Known immunization or hypersensitivity to any botulinum toxin serotype. * Any medical condition that may put the participant at increased medical risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function. * Rosacea, skin infection, or any other skin disease or disorder that would represent a safety concern and/or interfere with the ability to either administer treatment or assess the treatment effect, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Potential Clinically Significant (PCS) changes in physical exams | Baseline (Day 1) to Final Visit (up to Day 97) | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit. |
| Number of Participants with injection site pain/discomfort. | Baseline (Day 1) | Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment. |
| Number of Participants with Potential Clinically Significant (PCS) changes in vital signs | Baseline (Day 1) to Final Visit (up to Day 97) | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit. |
| Number of Participants with Adverse Events (AEs) | Baseline (Day 1) to Final Visit (up to Day 97) | Unique number of participants who experience one or more treatment emergent adverse event |
Countries
United States
Outcome results
None listed