Clinical trial NCT04631588: Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
Official title: Phase 1b Safety and Tolerability of Intradermal BOTOX® (OnabotulinumtoxinA) Purified Neurotoxin Complex in Participants With Facial Fine Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Facial Fine Lines
Keywords: Facial Fine Lines,BOTOX,Onabotulinum Toxin A
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline (Day 1) to Final Visit (up to Day 97)
measure: Number of Participants with Potential Clinically Significant (PCS) changes in vital signs
timeFrame: Baseline (Day 1) to Final Visit (up to Day 97)
measure: Number of Participants with Potential Clinically Significant (PCS) changes in physical exams
timeFrame: Baseline (Day 1) to Final Visit (up to Day 97)
measure: Number of Participants with injection site pain/discomfort.
timeFrame: Baseline (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Skin and Cancer Associates, LLP /ID# 225152
state: Florida
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York /ID# 225153
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center /ID# 225151
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 225154
state: Texas
city: Salt Lake City
country: United States
facility: Advanced Clinical Research /ID# 225155
state: Utah
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: