Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT04240535
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04240535
Study Brief:
Protocol Section:
NCT04240535