Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01297634
Eligibility Criteria:
Inclusion Criteria:
* Subjects who have indication for aesthetic treatment of the frontal dynamic wrinkles, in maximal contraction of the frontal muscle.
* Availability and understanding of the patient, for complete all the steps throughout the duration of the study.
* Medical history and physical examination compatible with the study.
* Informed consent signed.
Exclusion Criteria:
* Subjects with previous forehead face lifting or blepharoplasty surgery.
* Previous use of Botulinum toxin in the last 6 months.
* Forehead or eyelid asymmetry.
* Subjects with infections on site of injection or inflammatory skin diseases.
* Subjects with hypersensitivity to any component of the formulation, including albumin.
* Subjects with neuropathic or neuromuscular diseases.
* Subjects using aminoglycosides, penicillamine antibiotics, quinine and Ca2+ channel blockers.
* Subjects with pregnancy and lactation, or that planning become pregnant during the time of the study.
* Subjects with dimorphism or others psychological disorders.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT01297634
Study Brief:
Protocol Section:
NCT01297634