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

NCT04240535 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: MMD103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• One grade improvement on Depressor Anguli Oris Scale

  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

  2 weeks Post Treatment

Secondary Outcomes (5)

• Improvement on Investigator Global Aesthetic Improvement Scale

  2 weeks Post Treatment

• Improvement on Subject Global Aesthetic Scale

  2 weeks Post Treatment

• Patient Satisfaction Questionnaire

  2 weeks Post Treatment

• Photographic Analysis

  2 weeks Post Treatment

• Safety Assessments such as Focused Physical & adverse event, or expected treatment effects

  12 weeks Post Treatment

Study Arms (2)

Active- onabotulinumtoxinA

EXPERIMENTAL

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]

Placebo-Bacteriostatic 0.9% Sodium Chloride

PLACEBO COMPARATOR

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]

Interventions

OnabotulinumtoxinA 50 UNT [Botox Cosmetic] DRUG

Injections to the Depressor Anguli Oris

Also known as: Botox Cosmetic

Active- onabotulinumtoxinA; Placebo-Bacteriostatic 0.9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
• Male or non-pregnant, non-breastfeeding females
• Age ranging between 18-65
• Subject seeking augmentation therapy of the depressor anguli oris.
• 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.)
• 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.
• Subjects willing to provide written consent for use of photography -

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Amir Moradi MD, MBA: lead
• Allergan: collaborator

Study Sites (1)

Moradi MD

Vista, California, 92083, United States

Location

Related Publications (1)

• Moradi A, Khalifian S, Alghoul MS, Poehler J. A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris. Dermatol Surg. 2023 Mar 1;49(3):259-265. doi: 10.1097/DSS.0000000000003695. Epub 2023 Feb 10.

  PMID: 36763899 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Amir Moradi, MD, MBA

  Moradi MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Poehler, BA, CCRC

CONTACT

(760) 726-6451; jeanette@moradimd.com

Joceline De Leon, BA

CONTACT

(760) 726-6451; joceline@moradimd.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)