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
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
K. Kay Durairaj, MD, FACS, A Medical Corporation
Pasadena, California, United States
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
Time frame: 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.
Time frame: Up to 14 weeks
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 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?
Time frame: Up to 14 weeks