Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this clinical trial is to test the efficacy of Calcium Hydroxylapatite (CaHA) in treating cellulite dimples in the buttocks. Participants will:

• have 3 treatment sessions at weeks 0, 4, and 8 and a final live assessment visit at week 14

• receive approximately 2 syringes per side of the buttocks, per treatment session

• have their pictures taken before and after each treatment session, and once more during the final visit

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kalpna Kay Durairaj, MD, FACS
• Collaborator: Merz North America, Inc.
• Treatments: Calcium

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.