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 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT05064761
Eligibility Criteria:
Inclusion Criteria:
* Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.
Exclusion Criteria:
* Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
* Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve blocking agents.
* Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
* Previous treatment/procedure in or near the treatment area:
1. Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, regardless of time.
2. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.
3. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.
4. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and endermology) in the treatment area within 6 months.
5. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. chemical peel) in the treatment area within 6 months.
6. Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the treatment area within 6 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05064761
Study Brief:
Protocol Section:
NCT05064761