Facial Fine Lines Clinical Trial
Official title:
Phase 1b Safety and Tolerability of Intradermal BOTOX® (OnabotulinumtoxinA) Purified Neurotoxin Complex in Participants With Facial Fine Lines
| Verified date | November 2021 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
| Status | Completed |
| Enrollment | 172 |
| Est. completion date | November 3, 2021 |
| Est. primary completion date | November 3, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Skin and Cancer Associates, LLP /ID# 225152 | Miami | Florida |
| United States | Tennessee Clinical Research Center /ID# 225151 | Nashville | Tennessee |
| United States | Laser & Skin Surgery Center of New York /ID# 225153 | New York | New York |
| United States | Austin Institute for Clinical Research /ID# 225154 | Pflugerville | Texas |
| United States | Advanced Clinical Research /ID# 225155 | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants with Adverse Events (AEs) | Unique number of participants who experience one or more treatment emergent adverse event | Baseline (Day 1) to Final Visit (up to Day 97) | |
| Primary | Number of Participants with Potential Clinically Significant (PCS) changes in vital signs | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in vital signs from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) | |
| Primary | Number of Participants with Potential Clinically Significant (PCS) changes in physical exams | Unique number of participants who experience one or more Potential Clinically Significant (PCS) change in physical exams from the Baseline visit. | Baseline (Day 1) to Final Visit (up to Day 97) | |
| Primary | Number of Participants with injection site pain/discomfort. | Unique number of participants who experience injection site pain and/or discomfort at the injection site during administration of treatment. | Baseline (Day 1) |