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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT02907268
Eligibility Criteria:
Inclusion Criteria:
* Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles in the following areas: glabella (forehead frowns), periorbital area (crows feet). Static wrinkles in additional areas of the face are also acceptable.
* Subject is willing to maintain the same skin care regimen throughout the study and has already maintained this skin care regime for 4 weeks prior to baseline.
* The subject is able to comply with study procedures and instructions and is committed to attend all study visits within the given timelines.
* Subject is judged to be a good candidate by study nurse upon identification of dynamic and/or static wrinkles in the areas of movement, and with a moderate amount of skin laxity.
* Subject is willing to use contraception
* A signed informed consent form by a subject able to give consent, prior to any study procedures are performed.
Exclusion Criteria:
* Sensitivity and/or contraindications to botulinum toxin A other ingredients contained in the botulinum toxin A products.
* Any medical condition, in the opinion of the investigator, that would interfere with safety or any study procedures (e.g. auto-immune disease, history of severe allergies, hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints at injection sites, unable to give consent)
* Treatment with botulinum toxin A injections in the neck or face within 1 year of baseline treatment
* Treatment with facial fillers less than 1 year prior to baseline
* Females of childbearing potential who are pregnant, breastfeeding or plan to get pregnant during the course of the study.
* Previous treatment with Lasers, Ultrasound Technology or Radio Frequency on the face and/or neck within 1 year prior to baseline.
* Treatment with Accutane (isotretinoin) or other oral medications for acne during 1 year prior to baseline.
* The use of anti-aging products containing retinol
* Known allergy to cow's milk protein
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT02907268
Study Brief:
Protocol Section:
NCT02907268