evaluation the effect of botulinum toxin type A for treating frown lines

Phase 2

Recruiting

• Conditions: skin rejuvenation.

• Registration Number: IRCT20150101020514N8
• Lead Sponsor: Imen vaccine alborz Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Men and women with 18 to 75 years old
mild to moderate Glabellar Lines
signing informed consent form

Exclusion Criteria

Hypersensitivity to botulinum toxin or other components of formulation
History of treatment with botulinum toxin in face area within the past 6 months
History of using aminoglycosides, penicillin, kinin, chloroquine,Calcium Channel Blockers, warfarin and aspirin
History of injectable filler, chemical peels and laser treatment of any type within the past year
Significant scarring ,skin disorder or wound infection in the facial area
Neuro-muscular disorders like miastenia gravis, iron lambert , ALS
Significant face asymmetry
Any active, chronic and recurrent infection
Pregnancy/ breast feeding

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glabellar line severity scale. Timepoint: before intervention and 3, 7, 14, 30, 60, 90 and 120 days later. Method of measurement: physical examination.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: before intervention and 60, 90 and 120 days later. Method of measurement: GLSS.;Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;Percentage of subjects with improvement in Glabellar Lines at rest using SSA scoring. Timepoint: before intervention and 30 and 120 days later. Method of measurement: Subject Self Assessment (SSA).;The onset and duration of the effect of two groups. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.;Adverse effects. Timepoint: Days 3, 7, 14, 30, 60, 90, 120 after treatment. Method of measurement: Clinical assessment.