A prospective, Phase IV, multi-center, open label, Single dose clinical study to demonstrate the safety and efficacy of DYSPORTÂ® in adult subjects for treatment of moderate-to-severe glabellar lines

Cliniexperts Services Private Limited0 sites105 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 5, 2019

Last Updated

4 years ago

Study Type

Observational

Sponsor

Cliniexperts Services Private Limited

•1\.Subjects is an adult, of at least 18\-65 years of age
•2\.Subject has grade 2\-3 moderate to severe glabellar lines at maximum frown as assessed by the investigator using 4\-point photographic glabellar line severity scale (GLSS)
•3\.Subject is willing and able to complete the entire course of the study as per the study protocol.
•4\.Subject is able to provide informed consent and comply with study instructions

•1\.Previous treatment with botulinum toxin of any serotype in any area within the last 6 months.
•2\.Previous treatment with any facial aesthetic procedure (e.g. injection with fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
•3\.Previous insertion of permanent material in the glabellar area
•4\.Planned treatment with botulinum toxin of any serotype in any other body region during the study period
•5\.Any surgery in the glabellar area including surgical removal of the corrugators, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
•6\.Energy\-based or cryo\-therapy based treatment of facial muscles superior to the lateral canthus
•7\.Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (subjects can continue with their usual skin care routine)
•8\.Marked facial asymmetry
•9\. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
•10\.History of facial nerve palsy