The onset of action and safety of Dyston in glabellar lines improvement

Phase 4

• Conditions: Glabellar frown lines.; Changes in skin texture; R23.4

• Registration Number: IRCT20180515039672N3
• Lead Sponsor: Imen Vaccine Alborz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The onset of action. Timepoint: Daily (immediately after injection till 14 days). Method of measurement: Average (day).;Adverse events. Timepoint: Daily (immediately after injection till 14 days). Method of measurement: Percentage.