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

• Status: Not yet recruiting
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amir Moradi MD, MBA
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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