Clinical trial to compare efficacy and safety of Abobotulinum toxin A(Espad Pharmed) versus Abobotulinum toxin A(Dysport®, Ipsen Co.)
- Conditions
- skin rejuvenation.
- Registration Number
- IRCT20150101020514N23
- Lead Sponsor
- Espad pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 146
Men and women with 18 to 65 years old
Mild to moderate Glabellar Lines
Signing informed consent form
Previous treatment in the glabellar area within 12 months prior to randomization
History of facial plastic surgery, eyebrow lift and dermal resurfacing
History of inserting non-absorbent substances or surgery to remove the glabellar muscle.
Severe atrophy in glabellar area
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
Active infection in injection area
Facial expressions that can impair safety or efficacy outcomes.
Neuromuscular connectivity disorders
Current treatment with drugs that interfere with neuromuscular function.
Allergies to botulinum neurotoxin as well as injectable fillers in the facial area
Participate in another research study on botulinum neurotoxin products and fillers in the last 6 months
Any other condition that may expose a risk to the volunteer during the study or disrupt safety or efficacy outcomes
Pregnancy/ breast feeding
History of eyebrow tattoo or any other procedure in the eyebrow area during the last month
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