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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT03225066
Eligibility Criteria:
Inclusion Criteria:
1. Female;
2. Age between 35 and 60 years (including 60 years);
3. Indication for treatment of bilateral skin flaccidity of at least one of two corporal areas candidate for treatment (arms \[anteromedial region\] or gluteal regions);
4. Mild to moderate flaccidity in the area to be treated, according to investigator's assessment and in accordance with appropriated flaccidity scales for corporal region to be treated;
5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure
Exclusion Criteria:
1. Prior use (\<1 year) or planning to use any other aesthetic treatment in the corporal area of interest for study, such as radiofrequency, cryolipolysis;
2. History of liposuction, plastic surgery and / or corrective plastic surgery in the area of the body of interest for the study (arms or gluteal region);
3. History (\<1year) of treatment with Sculptra in other corporal area, area without interest for study;
4. History of Sculptra treatment in the area of the body of interest for the study (arms or gluteal region);
5. Any type of comorbidity or clinical condition that, at investigator s discretion, could interfere with study assessments;
6. Using or planning to initiate restrictive diets (at investigator s discretion);
7. Using or planning to initiate use of supplements for weight loss;
8. Diabetes mellitus type 1 or type 2;
9. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
10. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
11. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
12. Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon;
13. Pregnant or breastfeeding, or wishes to get pregnant within the next 18 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT03225066
Study Brief:
Protocol Section:
NCT03225066