Evaluation of the Safety and Efficacy of OnabotulinumtoxinA to the Depressor Anguli Oris

Part of paid clinical trials in Vista, California.

Sponsor
Amir Moradi MD, MBA
Study ID
NCT04240535
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • OnabotulinumtoxinA 50 UNT [Botox Cosmetic] — DRUG
    Injections to the Depressor Anguli Oris

Study Details

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.

Key Dates

Start date
Jan 31, 2020
Status verified
Jan 2020
Primary completion
May 31, 2020
Completion
Jul 31, 2020

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active- onabotulinumtoxinA
    BOTOX Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
  • Placebo Comparator: Placebo-Bacteriostatic 0.9% Sodium Chloride
    Placebo subjects will have injections in the same manner, but will be injected with Bacteriostatic 0.9% Sodium Chloride.

Primary Outcome Measure

One grade improvement on Depressor Anguli Oris Scale [ Time Frame: 2 weeks Post Treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moradi MDVistaCalifornia92083
Jeanette Poehler, BA, CCRC
[email protected]
760-726-6451

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