Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

Conditions
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Cellulite

Intervention / Treatment
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* Drug: Calcium Hydroxyapatite


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The model group will consist of females who present with cellulite dimples in the buttocks. Women are ideal for this study because they have more cellulite dimpling and a predisposition to dimpling due to the anatomy of their fibrous septa.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated with hyperdilute Calcium Hydroxylapatite (CaHA)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale (GAIS) Rating | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Subjects will be contacted weekly to assess safety injection site and treatment responses. Questionnaire will consist of the 5 following questions: How are you feeling? What (if any) side effects are you experiencing? Are you experiencing pain as a result of treatment? Are you following the post-procedural instructions? Do you have any questions or concerns? | Up to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buttocks, Calcium hydroxylapatite, Hyperdilution, Hyperdiluted calcium hydroxylapatite, Minimally invasive, Gluteal augmentation