Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
Completed · Phase 1 · Has a placebo group
Conditions studied: Facial Fine Lines
In brief
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
Key facts
- Study ID
- NCT04631588
- Run by
- Allergan
- People needed
- 172
- Starts
- 2020-11-16
- Expected to finish
- 2021-11-03
- Last updated by the study team
- 2021-11-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Skin and Cancer Associates, LLP /ID# 225152 — Miami, Florida, United States
- Laser & Skin Surgery Center of New York /ID# 225153 — New York, New York, United States
- Tennessee Clinical Research Center /ID# 225151 — Nashville, Tennessee, United States
- Austin Institute for Clinical Research /ID# 225154 — Pflugerville, Texas, United States
- Advanced Clinical Research /ID# 225155 — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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