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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240535
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Amir Moradi MD, MBA, Moradi MD

Brief 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.


Condition or disease Intervention/treatment Phase
Aging Drug: OnabotulinumtoxinA 50 UNT [Botox Cosmetic] Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Center, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA to the Depressor Anguli Oris
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Cosmetics

Arm Intervention/treatment
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.
Drug: OnabotulinumtoxinA 50 UNT [Botox Cosmetic]
Injections to the Depressor Anguli Oris
Other Name: Botox Cosmetic

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.
Drug: OnabotulinumtoxinA 50 UNT [Botox Cosmetic]
Injections to the Depressor Anguli Oris
Other Name: Botox Cosmetic




Primary Outcome Measures :
  1. One grade improvement on Depressor Anguli Oris Scale [ Time Frame: 2 weeks Post Treatment ]
    The scale will be used to measure if the subject has had any grade improvement in the treated area since baseline. Scale measures the severity of the depressor Anguli Oris from a 0-none-3 Severe as explained in the Detailed description section 3


Secondary Outcome Measures :
  1. Improvement on Investigator Global Aesthetic Improvement Scale [ Time Frame: 2 weeks Post Treatment ]
    The Global Aesthetic Improvement Scale is a 5-point scale that rates global aesthetic improvement from the pretreatment appearance.Global Aesthetic Scale is defined in Detailed Description Section 4

  2. Improvement on Subject Global Aesthetic Scale [ Time Frame: 2 weeks Post Treatment ]
    The Global Aesthetic Improvement Scale is a 5-point scale that rates global aesthetic improvement from the pretreatment appearance.this one will be fore the subject. The Global Aesthetic Scale is defined in Detailed Description Section 4.

  3. Patient Satisfaction Questionnaire [ Time Frame: 2 weeks Post Treatment ]
    This questionnaire will be used to measure the level of satisfication if any since the subject was treated in the Depressor Anguli Oris. A detailed list of the questions is in the Detailed Description Section 4

  4. Photographic Analysis [ Time Frame: 2 weeks Post Treatment ]
    Analysis of photography to provide or confirm change in facial muscle contraction. Subjects will use the images help score when using the Using the subject Global aesthetic Scale.

  5. Safety Assessments such as Focused Physical & adverse event, or expected treatment effects [ Time Frame: 12 weeks Post Treatment ]
    Number of participants with treatment- related adverse events as assessed by Principal Investigator will occur at each visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test at the screening/enrollment visit and prior to treatment.

    Acceptable forms of effective birth control include:

    Barrier methods of contraception: Condom or Occlusive cap

    • (diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
    • Bilateral tubal ligation;
    • Combined oral contraceptives (estrogens and progesterone), implanted or Injectable contraceptives on a stable dose for at least 28 days prior to Day 1;
    • Hormonal or copper intra uterine device (IUD) inserted at least 28 days prior to Day 1;
    • Vasectomized partner (in monogamous relationship) for at least 3 months prior to screening;
    • Strict abstinence (at least one month prior to baseline and agrees to continue for the duration of the study or use acceptable form of birth control). Negative urine pregnancy test at screening.
  7. Subjects willing to provide written consent for use of photography -

Exclusion Criteria:

  1. History of other facial treatment/procedure in the previous 6 months below the level of the horizontal line from sub nasal that, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation.
  2. Presence of any disease or lesions near or on the area to be treated:

    • Inflammation, active or chronic infection (e.g., in mouth, dentals, head and neck region);
    • Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or herpes zoster;
    • Scars or deformities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240535


Contacts
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Contact: Jeanette Poehler, BA, CCRC (760) 726-6451 jeanette@moradimd.com
Contact: Joceline De Leon, BA (760) 726-6451 joceline@moradimd.com

Locations
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United States, California
Moradi MD
Vista, California, United States, 92083
Contact: Jeanette Poehler, BA, CCRC    760-726-6451    jeanette@moradimd.com   
Sponsors and Collaborators
Amir Moradi MD, MBA
Allergan
Investigators
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Principal Investigator: Amir Moradi, MD, MBA Moradi MD
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Responsible Party: Amir Moradi MD, MBA, Principal Investigator, Moradi MD
ClinicalTrials.gov Identifier: NCT04240535    
Other Study ID Numbers: MMD103
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents