AI-09 In Subjects with Glabellar Lines
A Phase 1/2, multicenter, out-patient, prospectively randomized, double-blind, vehicle-controlled study to establish an initial therapeutic range for AI-09 in the treatment of glabellar lines and provide initial data regarding its potential safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Eirion Research Site
Boca Raton, Florida, United States
Eirion Research Site
Miami, Florida, United States
Eirion Research Site
New Brighton, Minnesota, United States
Eirion Research Site
Plano, Texas, United States
Percentage of Responders by Dose Group at the Week 4 Visit; R=I+S-C≤1
Investigator and Subject Assessment (R=I+S-C≤1), percentage of responders achieving a score of 0 (Absent) or 1 (Mild) on the Glabellar Line Severity scale where severity is scored between 0-3 (0=absent; 3=severe).
Time frame: 4 Weeks
% of Responders at Week 4 With Improvement From Baseline On-contraction by at Least 2 Points by Investigator and Subject's Self Assessment (I+S-C CfB≥2), on the Glabellar Line Severity Scale Where Severity is Scored Between 0-3 (0=Absent; 3=Severe).
% of responders with improvement in the Investigator and Subject's Self Assessment on Contraction, IGA-C, using the Glabellar Line Severity scale (GLS), where severity is scored between 0-3 (0=absent; 3=severe). A "responder" is defined as a change by at least two ordinals assessments.
Time frame: 4 Weeks
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