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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT02726451
Eligibility Criteria:
Inclusion Criteria:
* Subject is a female between the ages of 21 and 60;
* Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI or designee;
* Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
* Subject is willing and able to comply with the protocol requirements; and
* Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup.
Exclusion Criteria:
* Subjects who have received any facial filler in the 12-month or neurotoxin treatments in the 4-month period prior to enrollment;
* Previous treatment with any resurfacing facial aesthetic procedure (e.g. deep chemical peeling and laser treatments) within the 12-month period prior to enrollment;
* Previous treatment with photo rejuvenation therapy within the 6-month period prior to enrollment;
* Subjects who plan to undergo facial cosmetic surgery or any aesthetic procedure (e.g. neurotoxins, dermal fillers, laser treatments, and chemical peels), which are not specified in this protocol, during the course of the study;
* A known allergy or sensitivity to any component of the study ingredients;
* Use of systemic steroids or anticoagulation medications;
* Subjects with a history of bleeding disorders;
* Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
* Subjects with hypersensitivity to botulinum neurotoxin;
* Subject with allergies to gram positive bacterial proteins;
* Sensitivity to sulfides;
* Subjects with allergy to cow's milk protein;
* Subjects with previous history of sensitivity to amide type local anesthetics;
* Subject with surgical alterations to the facial anatomy or marked facial asymmetry;
* Inflammation or infection at the injection site(s);
* Subjects with a history of eyelid or eyebrow ptosis;
* Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin;
* Subjects with neuromuscular disorders;
* Use of anticholinergic, aminoglycosides or other agents that interfere with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants;
* Subjects with immunodeficiencies such as HIV, lupus, scleroderma, and systemic infections;
* Pregnant, nursing, or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence);
* Current history of chronic drug or alcohol abuse;
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
* Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
* Enrollment in any active study involving the use of investigational devices or drugs.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT02726451
Study Brief:
Protocol Section:
NCT02726451