None listed
Conditions
Interventions
Intervention1: Botulinum Toxin Type A: 75 patients will be recruited for forehead lines & glabellar frown lines indications treatment
50 patients who seeking for treatment will be enrolled in the stud
Sponsors
Gufic Biosciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 75 patients Age 18 to 40 years Male and Female 35 and 40 Indication Glabellar Frown lines and Forehead lines Grade 1 and 2 Skin type III, IV, and V Ethnicity Indian origin Body mass index less than 35
Exclusion criteria
Exclusion criteria: Known hypersensitivity to Botulinum Toxin type A. Subjects with neuromuscular disorders (Myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or motor neuropathy). Subjects who used medications that interfere with the neuromuscular function, such as aminoglycoside antibiotics and curare-like agents, within 4 weeks before screening. Subjects with a previous injection of Botulinum toxin type A within 4 months associated with forehead lines and glabellar frown lines. Pregnancy and lactation (Category C) Unwilling or inability to report for follow up at given intervals as dictated by the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of forehead lines will be assessed, using a facial wrinkle scale (FWS) Onset of effect Duration of effectTimepoint: 1, 0, 1, 4, 8, 12, 16, & 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the onset of effect of StunnoxTM on the forehead lines and glabellar frown lines Timepoint: 1, 4 weeks;To study the duration of effect of StunnoxTM on the forehead lines and glabellar frown linesTimepoint: 4, 8, 12, 16, & 20 weeks | — |
Countries
India
Contacts
Public ContactSandeep Arora
Mehektagul Dermaclinic
Outcome results
None listed