A Phase 1 interventional study of Calcium Hydroxyapatite in Cellulite, sponsored by Kalpna Kay Durairaj, MD, FACS. Completed at 1 site in United States. Open to female participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Kalpna Kay Durairaj, MD, FACS · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to test the efficacy of Calcium Hydroxylapatite (CaHA) in treating cellulite dimples in the buttocks. Participants will:
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.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 25 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Kalpna Kay Durairaj, MD, FACS is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Plan to share: Yes — 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.
Supporting information: Study protocol
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.
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.
Ran from Jan 2023 to primary completion in Jun 2023, 5 months.
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Studies of the drug tested here: Durapatite
Kalpna Kay Durairaj, MD, FACS