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Study of OnabotulinumtoxinA for Depressor Anguli Oris

This study is looking at the safety and effectiveness of OnabotulinumtoxinA (Botox Cosmetic) injections to the depressor anguli oris, a muscle that pulls down the corners of your mouth. Researchers want to see if these injections can improve the appearance of aging in this area. You may be able to join if you are between 18 and 65 years old, male or a non-pregnant, non-breastfeeding female, and are interested in improving the appearance of your depressor anguli oris. The study will be considered successful if participants show at least a one-grade improvement on a special scale that measures the pull-down of the mouth corners. The current status of this study is unclear, but it plans to enroll 20 participants.

Study design
This is a single-center, double-blind, placebo-controlled study involving 20 participants. Half will receive OnabotulinumtoxinA and half will receive a placebo.
What's involved
You will receive injections of either the study drug or a placebo. Follow-up visits will occur at 2, 4, and 12 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after treatment to assess improvements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04240535

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

Not Yet Recruiting
PHASE4Ages 18–65InterventionalTreatment
Amir Moradi MD, MBA
~20 participants
Updated 2020-01-27 on ClinicalTrials.gov
What's tested:OnabotulinumtoxinA 50 UNT [Botox Cosmetic]

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One grade improvement on Depressor Anguli Oris Scale
Measured over 2 weeks Post Treatment

Conditions

Aging

Explore related trials

Aging

NCT04240535

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Moradi MD

    Vista, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amir Moradi, MD, MBA · PRINCIPAL_INVESTIGATOR · Moradi MD

Who to contact

Jeanette Poehler, BA, CCRC
[email protected]
(760) 726-6451
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

(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

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

What this trial measures

  • One grade improvement on Depressor Anguli Oris Scale2 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