Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

July 13, 2023 updated by: Kalpna Kay Durairaj, MD, FACS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • K. Kay Durairaj, MD, FACS, A Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS) Rating
Time Frame: Up to 14 weeks

The treating physician will rate the subject after the final treatment. Based on aesthetic appearance, qualitative success of treatment will be evaluated using the GAIS. Aesthetic appearance will be rated one of the five following options:

  • Worse: The appearance is worse than the original condition
  • No Change: The appearance is essentially the same as the original condition
  • Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
  • Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
  • Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 14 weeks
Cellulite Severity Scale (CSS) Rating
Time Frame: Up to 14 weeks
The treating physician and the blinded, secondary physician will rate the subject after the final treatment. The scale identifies 5 key clinical morphologic features of cellulite: (1) number of evident depressions, (2) depth of depressions, (3) morphologic appearance of skin surface alterations, (4) grade of laxity, flaccidity, or sagging skin, and (5) the classification scale originally described by Nurnberger and Muller. The scale has 4 points to describe each feature of cellulite: Stage 0 is no dimpling in relaxed or contracted states, Stage 1 implies no dimpling upon relaxed states but dimpling during muscle contraction or skin pinching, Stage 2 implies dimpling appears spontaneously when standing but not when lying down, and Stage 3 implies dimpling is spontaneously present when both standing and lying down and is evident to the naked eye.
Up to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS) Rating
Time Frame: Up to 8 weeks

Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician using the GAIS. Aesthetic appearance will be rated one of the five following options:

  • Worse: The appearance is worse than the original condition
  • No Change: The appearance is essentially the same as the original condition
  • Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
  • Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
  • Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 8 weeks
Global Aesthetic Improvement Scale (GAIS) Rating
Time Frame: Up to 14 weeks

Based on aesthetic appearance, qualitative success of treatment will be self-evaluated by subjects using the GAIS. Aesthetic appearance will be rated one of the five following options:

  • Worse: The appearance is worse than the original condition
  • No Change: The appearance is essentially the same as the original condition
  • Improved: Obvious improvement in appearance from the initial condition, but a touchup or re-treatment is indicated
  • Much Improved: Marked improvement in appearance but not completely optimal for this patient. A touchup would slightly improve the result
  • Very Much Improved: Optimal cosmetic result for the treatment in this patient
Up to 14 weeks
Cellulite Severity Scale (CSS) Rating
Time Frame: Up to 8 weeks
The treating physician and the blinded, secondary physician will rate the subject at each treatment visit using the CSS Rating. The scale identifies 5 key clinical morphologic features of cellulite: (1) number of evident depressions, (2) depth of depressions, (3) morphologic appearance of skin surface alterations, (4) grade of laxity, flaccidity, or sagging skin, and (5) the classification scale originally described by Nurnberger and Muller. The scale has 4 points to describe each feature of cellulite: Stage 0 is no dimpling in relaxed or contracted states, Stage 1 implies no dimpling upon relaxed states but dimpling during muscle contraction or skin pinching, Stage 2 implies dimpling appears spontaneously when standing but not when lying down, and Stage 3 implies dimpling is spontaneously present when both standing and lying down and is evident to the naked eye.
Up to 8 weeks
Patient Satisfaction of Aesthetic Appearance
Time Frame: Up to 14 weeks
Subjects will rate their satisfaction of aesthetic appearance of their buttocks at each treatment and at the final assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied.
Up to 14 weeks
Patient Treatment Satisfaction
Time Frame: Up to 14 weeks
Subjects will rate their satisfaction of the treatment at each treatment visit and at the final assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied.
Up to 14 weeks
Telephone Assessment
Time Frame: Up to 14 weeks

Subjects will be contacted weekly to assess safety injection site and treatment responses. Questionnaire will consist of the 5 following questions:

  1. How are you feeling?
  2. What (if any) side effects are you experiencing?
  3. Are you experiencing pain as a result of treatment?
  4. Are you following the post-procedural instructions?
  5. Do you have any questions or concerns?
Up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kalpna Kay Durairaj, MD, FACS

Collaborators

Merz North America, Inc.

Investigators

  • Principal Investigator: Kalpna K Durairaj, MD, K. Kay Durairaj, MD, FACS, A Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

June 26, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KD2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data obtained through this study may be provided to qualified researchers with interest in calcium hydroxyapatite and cellulite dimpling. Individual participant data that underlies the results reported in this article will be shared after identification. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Furthermore, the proposed use of trial IPD must be approved with an Independent Review Committee prior to any data sharing.

IPD Sharing Time Frame

Data will become available beginning 12 months and ending 28 months after article publication. Upon approval of a data sharing request, data will be accessible to researchers for up to 3 months.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact research@beautybydrkay.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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