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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT04839692
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
* In good general health, based on answers provided during the screening visit;
* Subjects must be able to read and understand English;
* Caucasian female;
* Aged 21-30 years and post-menopausal;
* Skin Types (all Fitzpatrick Skin Phototypes );
* Smoking history is self-report.
* Have very thin to moderately thick lips (Lip Fullness Grading Scale \[LFGS\] scores 0-2).
Exclusion Criteria:
* Participation in another investigational drug or device clinical trial in the past 30 days;
* Are pregnant or lactating;
* Intake of hormone replacement therapy (HRT) in the past 6 months;
* Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day \[e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks\];
* Presence of eczema, psoriasis, or any other skin disease on the lips or perioral skin;
* Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
* Use of any anti-aging skin care products containing retinoic acid, retinol, or other retinoids (e.g. tazarotene, adapalene) or estrogen on the skin area of interest in the past 6 months;
* Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
* Have a history of photodynamic therapy treatment or any skin rejuvenation procedure on the skin area of interest;
* History of blood-clotting abnormality;
* History of keloid formation or hypertrophic scarring;
* Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
* Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
* Is not able to follow study protocol;
* Have permanent lip implant, and lip enhancement or laser therapy performed within the preceding 12 months;
* Known history of allergy or sensitivity to glycerol, Tegaderm, lidocaine, hyaluronic acid dermal fillers or materials with gram-positive bacterial proteins.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04839692
Study Brief:
Protocol Section:
NCT04839692