Efficacy and safety of Abobotulinum toxin A Elletox versus Dysprt® for correction of glabellar line

Phase 3

Recruiting

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

• Registration Number: IRCT20150101020514N30
• Lead Sponsor: ano Darou Pajouhan Pardis Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Men and women with 18 to 65 years old
Mild to moderate Glabellar Lines
Signing informed consent form

Exclusion Criteria

Allergies to botulinum toxin or any other compound in the formulation
Previous treatment with botulinum toxin within the last 6 months
History of filler injection in glabellar area during the last year
History of any alergic reaction to injectable fillers in the facial area
History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
Planned Facial Cosmetic Surgery (such as filler injection, chemical peeling and laser) Using products that cause skin remodeling or active changes on the forehead area and History of any cosmetic surgery in glabellar area in the last 6 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with improvement in Glabellar Lines at maximum frown. Timepoint: 30 days after intervention. Method of measurement: GLSS (Glabellar Lines Severity Score).

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with improvement in Glabellar Lines at resting. Timepoint: Before intervention, 14, 30, 90 and 120 days later. Method of measurement: GLSS (Glabellar Lines Severity Score).;Percentage of subjects with improvement in Glabellar Lines at maximum frown using SSA scoring. Timepoint: Before intervention, 14, 30, 90 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, 14, 30, 90 and 120 days later. Method of measurement: Subject Self-Assessment (SSA).