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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT06544304
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 60 years old;
* Signed Informed Consent Form (ICF);
* Participant understands and is willing to participate in the clinical study and attend visits.
Exclusion Criteria:
* Known history of allergy to formula components;
* Have the following morbidities (or any other disease that may interfere with the study): chronic inflammatory disease, immunosuppression, diabetes, hypertension, autoimmune disease, dermatological disease in the region to be treated, acute or chronic renal failure, history of coronary disease, history of cerebrovascular disease, current neoplasia, mental illness undergoing psychiatric treatment, obesity with a BMI above 30, asthma, bronchitis, seizures, hepatitis or other active infectious diseases;
* Pregnancy;
* Prior filling of glutes;
* Use of acetylsalicylic acid, anti-inflammatories, anticoagulants, in the fifteen days before the procedure.
* Vitamin D supplementation, with normal serum levels and which you do not agree to suspend;
* Use of anabolic hormones;
* Vitamin D (25 hydroxyvitamin D) greater than 70 ng/mL;
* Serum calcium greater than 10 mg/dL;
* Patients with total body PMMA volume of 650mL or more.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06544304
Study Brief:
Protocol Section:
NCT06544304