- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03922464
Recruitment Status Completed
First Posted April 22, 2019
Last update posted April 10, 2020
This is a phase IV prospective, multicentre, single cohort, open-label clinical trial evaluating the efficacy and safety of Poly-L-lactic acid (Sculptra® Aesthetic) for the treatment of contour deformities of the buttocks region
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
2. Age between 30 and 60 years;
3. Indication for treatment of bilateral contour deformities;
4. Mild to moderate flaccidity in the area to be treated, according to investigator's
5. An intact immune system, as the bio-stimulatory effect of Sculptra® Aesthetic is
dependent on the host response. An intact immune system, as the bio-stimulatory effect
of Sculptra® Aesthetic is dependent on the host response. Immune function will be
evaluated through clinical history. Exclusions will consist of both primary (genetic)
and secondary (acquired) immune deficiencies. Examples include: HIV/AIDS,
chemotherapy, cancers (e.g., leukemia and lymphoma), certain autoimmune diseases
(e.g., myasthenia gravis, systemic lupus erythematosus), certain medications (e.g.,
corticosteroids, tumor necrosis factor inhibitors, anticonvulsants), and certain
chronic or congenital diseases. Any type of comorbidity or clinical condition will be
reviewed at the investigator's discretion.
6. . Subjects who understood and signed the Informed Consent Form (ICF) when entering the
study, before performing any investigational procedure.
1. Prior (i.e., <1 year) or planned use (for the duration of the study period) any other aesthetic treatment in the buttock region, such as radiofrequency, cryolipolysis, dermal subscision, plastic surgery, laser treatment, chemical peeling or any other procedure based on active dermal response; 2. Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments; 3. Using or planning to initiate restrictive diets (at investigator's discretion); 4. Using or planning to initiate use of supplements for weight loss; 5. Diabetes mellitus type 1 or type 2; 6. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments; 7. Using or have used within the previous 3 months drugs such as corticosteroids, immunosuppressants, anticoagulants or other collagen-production inhibitors; 8. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months; 9. Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon; 10. 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); 11. Sculptra® Aesthetic should not be used in any person who has hypersensitivity to any of the components of the product; 12. Active skin inflammation or infection in or near the treatment area; 13. Sculptra® Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring; 14. Sculptra® Aesthetic should not be used in patients with implants in the treated regions; 15. Possessing any of the contraindications for use of Sculptra® Aesthetic.
Erevna Innovations Inc
Erevna Innovations Inc.