Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

NCT ID: NCT05885035

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-06-26

Brief 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

Detailed Description

Twenty-five (25) subjects will be enrolled in the study. The patient's body fat composition will be measured by a digital full body composition scale, which will be used to determine the individual percent body fat and eligibility.

The subjects will have three treatment sessions at weeks 0, 4, and 8 and a final live assessment visit at week 14. Office visits will last for approximately two hours. All subjects will have photographs taken before and after each treatment session. Photographs will be taken with buttocks in a relaxed and flexed state. All pictures will be taken via the Quantificare Liveviz Infinity Pro and will be stored via a HIPAA-compliant server.

Subjects will be treated with subdermal injections of CaHA diluted 1:1 with normal saline solution and 1% Lidocaine after having their pictures taken. Subjects will be asked to lay in the prone position with exposed buttocks. Topical Lidocaine/Tetracaine 23%/7% ointment cream will be applied to the treatment sites. After 15 minutes of numbing, the topical anesthetic will be cleaned off with alcohol. Thereafter, subjects will be asked to stand in an upright position to easily mark the areas with cellulite dimpling. The subjects will also be asked to flex and relax their buttocks to let the physician assess the areas of dimpling. Subjects will go back to laying in prone position to receive subdermal injections of CaHA. Multiple, retrograde, linear injections using a standard 25G cannula will be performed with a threading technique by the treating physician. Post injection, a calming cream will be applied to the treated area while massaging in a circular motion for five minutes. Subjects will be called 24-48 hours after each treatment session to check up on comfort and answer questions.

The treating physician will rate each subject's cellulite dimples using the Cellulite Severity Scale (CSS) at each visit. The Global Aesthetic Improvement Scale (GAIS) will be used by the treating physician and subjects to rate aesthetic improvement at each visit after baseline. Subjects will also rate their overall aesthetic improvement and treatment satisfaction at each visit after baseline according to a 5-point scale: (1) Extremely dissatisfied, (2) Dissatisfied, (3) Slightly satisfied, (4) Satisfied, (5) Extremely satisfied. Before and after photos of treated patients will be independently evaluated by the blinded, secondary physician using the CSS scale at each time interval of photos taken.

Conditions

Cellulite

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Calcium Hydroxyapatite

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Kalpna Kay Durairaj, MD, FACS

OTHER

Sponsor Role: lead

Responsible Party

Kalpna Kay Durairaj, MD, FACS

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kalpna K Durairaj, MD

Role: PRINCIPAL_INVESTIGATOR

K. Kay Durairaj, MD, FACS, A Medical Corporation

Locations

K. Kay Durairaj, MD, FACS, A Medical Corporation

Pasadena, California, United States

Countries

United States

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Other Identifiers

KD2019

Identifier Type: -

Identifier Source: org_study_id