Healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Deep 12.5 units single dose IM injection of botulinum toxin type "A" of Plasma Darman Sarve Sepid Company in 3 points in glabelar area. Intervention 2: Intervention
Sponsors
Plasma Darman Sarve Sepid
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious clinical adverse event in head and neck related to intervention. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: Physical examination.;Any abnormal Lab. findings related to intervention. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: Lab tests.;Systemic serious adverse event related to intervention i.e. Dysphagia, muscular weakness, Allergic reactions. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: Physical examination and lab. tests.;Any serious dermal reaction in injection area. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: NCH & NIH guideline (Cancer Therapy Evaluation Program 13 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998).;Any serious dermal reaction in the places other than injection area. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: NCH & NIH guideline (Cancer Therapy Evaluation Program 13 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998).;Neurological adverse event in head and face related to intervention. Timepoint: Days: 0, 1, 3, 14 and 28. Method of measurement: Physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in score of Glabellar Line in maximum frown. Timepoint: Days: 0 , 14 and 28. Method of measurement: Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS).;Changes in score of Glabellar Line in relax position. Timepoint: Days: 0 , 14 and 28. Method of measurement: Glabellar Line Scale (GLS) and Glabellar Line Severity Score (GLSS).;Patients self assessment. Timepoint: Days: 0 , 14 and 28. Method of measurement: Subject Satisfaction Scale (SSS).;Percent of participants that has 2 or more score reduction on GLSS. Timepoint: Days: 14 and 28. Method of measurement: Glabellar Line Severity Score (GLSS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ramin Heshmat
Tehran University of Medical Sciences
Outcome results
None listed