MedTrace Logo

Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

NCT05885035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-07-17

No results posted yet for this study

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

Conditions

  • Cellulite

Interventions

DRUG

Calcium Hydroxyapatite

Each syringe of CaHA contains 1.5 cc of product, and it will be diluted 1:1 with 1.0 cc of normal saline solution and 0.5 cc of 1% Lidocaine with a ratio of 1:100,000 epinephrine in the target sites.

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • Kalpna Kay Durairaj, MD, FACS

    lead OTHER

Principal Investigators

  • Kalpna K Durairaj, MD · K. Kay Durairaj, MD, FACS, A Medical Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-26
Completion
2023-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885035 on ClinicalTrials.gov