IRCT20180515039672N3
Completed
Phase 4
The Phase IV study for assessment of the onset of action and Treatment EmergentAdverse Events of Dyston (Botulinum Toxin Type A- ImenVaccine Co.) in Glabellar Lines Improvement
Imen Vaccine Alborz0 sites184 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Imen Vaccine Alborz
- Enrollment
- 184
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 75 year old volunteer
- •Moderate to severe glabellar lines at maximum frown
- •Signed an informed consent form
- •Being agree with 14\-day follow up
Exclusion Criteria
- •Hypersensitivity to botulinum toxin or any other ingredients in the formulation
- •Taking the following medicines: aminoglycosides, penicillamine, quinine, chloroquine, hydroxychloroquine, calcium channel blockers, Anticoagulants (warfarin and aspirin)
- •Any aesthetic surgery (e.g. fillers injection, chemical peeling, laser) or any other materials causing remodeling of the skin or active changes in the glabellar area within the last 12 months
- •Previous history of any surgery in the facial muscles or scars in the glabellar area and the surrounding areas (including eyebrows)
- •The medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton\-Lambert syndrome, amyotrophic lateral sclerosis)
- •History of facial nerve palsy
- •Marked facial asymmetry
- •History of the eyelid or eyebrow ptosis due to the facial muscle palsy
- •Any active infection or acute skin disease in the injection sites
- •Pregnant or lactating females
Outcomes
Primary Outcomes
Not specified
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