Comparison the efficacy and safety of botulinum toxin type A of Plasma Darman Sarve Sepid Company with Dysport® of Ipsen Co. in treatment of glabellar lines

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 202

Inclusion Criteria

Both genders
Age between 25- 55 years old
General health condition by medical history and physical examination
Moderate to severe Glabellar lines by GLS and GLSS criteria
Informed consent to participate in the study

Exclusion Criteria

Conditions that alter the safety results, like: eyelid ptosis or eyebrow ptosis; facial nerve paralysis; notable face asymmetry; overt dermatochalasis; deep dermal scar; thick sebaceous skin
Neuromuscular junction diseases i.e. Myasthenia Gravis; Eaton Lembert syndrome; Amyotrophic Lateral Sclerosis or other disease that alter neuromuscular function
Sever muscular atrophy or weakness in injection site
Previous injection of Botulinum neurotoxin in last 6 months
Participation in other trials related to Botulinum neurotoxin and fillers
History for hypersensitivity reaction to filler or gel injection or laser therapy in face area
History for Filler or gel injection in face
History for face plastic surgery i.e. tissue augmentation, eyebrow lifting or dermal resurfacing
History for cosmetic surgery (chemical peeling, laser) using materials that cause skin remodeling or active changes in forehead and near area (in 6 months).
History for eyebrow tattoo or other procedure in last month
History for insertion unabsorbable material or surgery to remove Corrugator? Procerus? Supercilli Depressor or combination therapy
Previous hypersensitivity or sever event after similar botulinum neurotoxin administration
Previous scar or surgery in eyebrow or forehead
Acute infection or dermal disease in injection site
Sever cardiovascular, respiratory disease or asthma
Planned cosmetic surgery during study
Intention to participate in other trial during study
Taking medications i.e. for Alzheimer disease (galantamine, rivastigmine, tacrine), Myasthenia gravis (ambenonium, pyridostigmine) and anticoagulants (warfarin, aspirin)
Taking medications: Aminoglycosides (gentamycin, ...), penicillamine, quinine, chloroquine, hydroxychloroquine, Calcium channel blockers one week before study
Pregnancy or breast feeding
Unwillingness to participate in the study
Not regularly participate in clinical visits and evaluations
Participate in any other clinical trial during the study
Happening sever hypersensitivity reactions related to botulinum neurotoxin till 30 minutes after injection
Happening serious unwanted event that participant needs to exit study by investigator's decision
Happening new or chronic condition that participant needs to exit study by investigator's decision