The safety and Effectiveness of Botulinum Toxin Type A used for treatment of Moderate to Severe Facial Wrinkles
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027413
- Lead Sponsor
- Gufic Biosciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
1) Male/Femles of 30-50 years of age
2) Subject who can and willing to provide written informed conscent
3)Subjects motivated and aesthetically conscious with moderate to severe facial wrinkles
4)Females of child bearing potential must have negative urine pregnancy test, must be practicing a medically acceptable method of birth control and not lactating
1)Subjects with a known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
2) Subjects with a known allergy or sensitivity to any of the study medication or their components
3) Subjects having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
4) Subjects has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration
5) Subjects with a history of vision loss not corrected by lenses, or LASIX surgery, glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease 6) Subjects with acute infection 7. Subject with myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
8) Concurrent use of aminoglycoside antibiotics that interfere with neuromuscular function
9) Subjects with history of previous injection of botulinum Toxin within eight months
10) Subjects with severe thin skin in treatment area as determined by the investigator
11) Subjects with infection at the injection site
12) Subjects having received anticoagulation, anti-platelet and thrombolytic treatment (eg Warfarin), anti-inflammatory drugs (NSAIDs aspirin, Ibuprofen, etc) or any other substance known to increase the coagulation time from 10 days pre to 3 days post injection
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method