Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Cellulite
About this trial
This is an interventional treatment trial for Cellulite focused on measuring Buttocks, Calcium hydroxylapatite, Hyperdilution, Hyperdiluted calcium hydroxylapatite, Minimally invasive, Gluteal augmentation
Eligibility Criteria
Inclusion Criteria: Females, 21-50 years old, of any race and ethnic background. 4-5 cellulite dimples that are no deeper than 1 cm each per buttock. Body fat between 9% and 55%. Written Authorization for Use and Release of Health and Research Study Information has been obtained. Ability to follow study instructions and likely to complete all required visits. Exclusion Criteria: Males Females who are pregnant, breastfeeding, chronically using nonsteroidal anti-inflammatory drugs, have autoimmune conditions or have a known allergy to the study medications. Subjects with piercings or tattoos on the buttocks or those prone to getting keloids. Subjects with any aesthetic treatment in the buttocks. Subjects with minimal or excessive subcutaneous fat. Scars or ongoing infections in the target areas. Presence of any clinically significant bleeding disorder or is receiving medication that may increase the risk of bleeding as the result of treatment. Subject has a condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. Any medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent.
Sites / Locations
- K. Kay Durairaj, MD, FACS, A Medical Corporation
Arms of the Study
Arm 1
Experimental
Treated with hyperdilute Calcium Hydroxylapatite (CaHA)
Subjects will have 3 treatment sessions at weeks 0, 4, and 8 and a final live assessment visit at week 14. Approximately two syringes of CaHA will be injected per side of the buttocks (at sites with cellulite dimpling) during each of the three treatment sessions.