Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
NCT ID: NCT04631588
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
172 participants
INTERVENTIONAL
2020-11-16
2021-11-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open Label BOTOX
Participants will receive BOTOX at Baseline (Day 1)
Botox
Intradermal (ID) injection
Double-Blind Randomized BOTOX
Participants will receive BOTOX at Baseline (Day 1)
Botox
Intradermal (ID) injection
Double Blind Randomized Placebo
Participants will receive placebo at Baseline (Day 1)
Placebo
Intradermal (ID) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botox
Intradermal (ID) injection
Placebo
Intradermal (ID) injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1940-102-008
Identifier Type: -
Identifier Source: org_study_id