The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
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
Number of Participants with Adverse Events (AEs)
Unique number of participants who experience one or more treatment emergent adverse event
Time frame: Baseline (Day 1) to Final Visit (up to Day 97)
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.
Time frame: Baseline (Day 1) to Final Visit (up to Day 97)
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.
Time frame: Baseline (Day 1) to Final Visit (up to Day 97)
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.
Time frame: Baseline (Day 1)
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Advanced Clinical Research /ID# 225155
Salt Lake City, Utah, United States