A Single Center, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA to the Depressor Anguli Oris
Amir Moradi MD, MBA
Summary
Single Center, Double Blind, Placebo- Controlled Study of 20 subjects with 10 active drug/10 placebo Standardized baseline/pre-treatments and follow-up images will be taken. Subjects will receive injection of either study drug or placebo to the Depressor Anguli Oris. Follow ups will occur at 2 weeks, 4 weeks, and 12 weeks.
Description
1. This study is a prospective single-center, clinical trial to be conducted at one clinical site. Up to 20 subjects will be enrolled and treated (total enrollment may be more than 20 due to screen failures) if they meet the inclusion/exclusion criteria and provide written informed consent. 2. Duration of Study The duration from when the study opens to enrollment until completion of data analysis is anticipated to be six months 3. Study Endpoints 3.1 Primary Endpoint: One grade improvement on Depressor Anguli Oris Scale as assessed by the Principal Investigator Depressor Anguli Oris Scale 0-…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subjects willing to comply with the requirements of the study and providing a signed written informed consent. 2. Male or non-pregnant, non-breastfeeding females 3. Age ranging between 18-65 4. Subject seeking augmentation therapy of the depressor anguli oris. 5. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the horizontal line from the sub nasal for the duration of the study. (e.g. laser or chemical peels, skin resurfacing, microdermabrasion, etc.) 6. If the subject is a female of childbearing potential, sh…
Interventions
- DrugOnabotulinumtoxinA 50 UNT [Botox Cosmetic]
Injections to the Depressor Anguli Oris
Location
- Moradi MDVista, California