Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Calcium Hydroxyapatite
Intervention type(s): Drug
Intervention description(s): 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 MeSH terms: Calcium
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Buttocks; Calcium hydroxylapatite; Hyperdilution; Hyperdiluted calcium hydroxylapatite; Minimally invasive; Gluteal augmentation