Clinical trial NCT05885035: Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Official title: Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cellulite
Keywords: Buttocks
Calcium hydroxylapatite
Hyperdilution
Hyperdiluted calcium hydroxylapatite
Minimally invasive
Gluteal augmentation
Lead sponsor: K. Kay Durairaj, MD, FACS, A Medical Corporation
Sponsor class: OTHER
Collaborators: name: Merz North America, Inc.
First posted: 2023-06-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 14 weeks
measure: Cellulite Severity Scale (CSS) Rating
timeFrame: Up to 14 weeks
Secondary outcomes:
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 8 weeks
measure: Global Aesthetic Improvement Scale (GAIS) Rating
timeFrame: Up to 14 weeks
measure: Cellulite Severity Scale (CSS) Rating
timeFrame: Up to 8 weeks
measure: Patient Satisfaction of Aesthetic Appearance
timeFrame: Up to 14 weeks
measure: Patient Treatment Satisfaction
timeFrame: Up to 14 weeks
measure: Telephone Assessment
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: K. Kay Durairaj, MD, FACS, A Medical Corporation
state: California
Study officials:
affiliation: K. Kay Durairaj, MD, FACS, A Medical Corporation
name: Kalpna K Durairaj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amore R, Amuso D, Leonardi V, Sbarbati A, Conti G, Albini M, Leva F, Terranova F, Guida A, Gkritzalas K, Gavashely L, Velichenko R. Treatment of Dimpling from Cellulite. Plast Reconstr Surg Glob Open. 2018 May 18;6(5):e1771. doi: 10.1097/GOX.0000000000001771. eCollection 2018 May.
citation: de Almeida AT, Figueredo V, da Cunha ALG, Casabona G, Costa de Faria JR, Alves EV, Sato M, Branco A, Guarnieri C, Palermo E. Consensus Recommendations for the Use of Hyperdiluted Calcium Hydroxyapatite (Radiesse) as a Face and Body Biostimulatory Agent. Plast Reconstr Surg Glob Open. 2019 Mar 14;7(3):e2160. doi: 10.1097/GOX.0000000000002160. eCollection 2019 Mar.
citation: Goldie K, Peeters W, Alghoul M, Butterwick K, Casabona G, Chao YYY, Costa J, Eviatar J, Fabi SG, Lupo M, Sattler G, Waldorf H, Yutskovskaya Y, Lorenc P. Global Consensus Guidelines for the Injection of Diluted and Hyperdiluted Calcium Hydroxylapatite for Skin Tightening. Dermatol Surg. 2018 Nov;44 Suppl 1:S32-S41. doi: 10.1097/DSS.0000000000001685.
citation: Casabona G, Marchese P. Calcium Hydroxylapatite Combined with Microneedling and Ascorbic Acid is Effective for Treating Stretch Marks. Plast Reconstr Surg Glob Open. 2017 Sep 26;5(9):e1474. doi: 10.1097/GOX.0000000000001474. eCollection 2017 Sep.
citation: Loghem JV, Yutskovskaya YA, Philip Werschler W. Calcium hydroxylapatite: over a decade of clinical experience. J Clin Aesthet Dermatol. 2015 Jan;8(1):38-49.
citation: Silvers SL, Eviatar JA, Echavez MI, Pappas AL. Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):34S-45S. doi: 10.1097/01.prs.0000234847.36020.52.
citation: Carruthers A, Liebeskind M, Carruthers J, Forster BB. Radiographic and computed tomographic studies of calcium hydroxylapatite for treatment of HIV-associated facial lipoatrophy and correction of nasolabial folds. Dermatol Surg. 2008 Jun;34 Suppl 1:S78-84. doi: 10.1111/j.1524-4725.2008.34247.x.
citation: Goldman MP, Moradi A, Gold MH, Friedmann DP, Alizadeh K, Adelglass JM, Katz BE. Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial. Dermatol Surg. 2018 Jan;44(1):75-83. doi: 10.1097/DSS.0000000000001203.
citation: Breithaupt A, Fitzgerald R. Collagen Stimulators: Poly-L-Lactic Acid and Calcium Hydroxyl Apatite. Facial Plast Surg Clin North Am. 2015 Nov;23(4):459-69. doi: 10.1016/j.fsc.2015.07.007.
citation: Lorenc ZP, Black JM, Cheung JS, Chiu A, Del Campo R, Durkin AJ, Graivier M, Green JB, Kwok GP, Marcus K, Rammos CB, Werschler WP. Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice. Aesthet Surg J. 2022 Jan 1;42(1):NP29-NP37. doi: 10.1093/asj/sjab269.
citation: Emer J, Sundaram H. Aesthetic applications of calcium hydroxylapatite volumizing filler: an evidence-based review and discussion of current concepts: (part 1 of 2). J Drugs Dermatol. 2013 Dec;12(12):1345-54.
citation: Cogorno Wasylkowski V. Body vectoring technique with Radiesse((R)) for tightening of the abdomen, thighs, and brachial zone. Clin Cosmet Investig Dermatol. 2015 May 19;8:267-73. doi: 10.2147/CCID.S75631. eCollection 2015.
citation: Chao YY, Kim JW, Kim J, Ko H, Goldie K. Hyperdilution of CaHA fillers for the improvement of age and hereditary volume deficits in East Asian patients. Clin Cosmet Investig Dermatol. 2018 Jul 16;11:357-363. doi: 10.2147/CCID.S159752. eCollection 2018.
citation: Jacovella PF. Calcium hydroxylapatite facial filler (Radiesse): indications, technique, and results. Clin Plast Surg. 2006 Oct;33(4):511-23. doi: 10.1016/j.cps.2006.08.002.
citation: Bass LS, Smith S, Busso M, McClaren M. Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthet Surg J. 2010 Mar;30(2):235-8. doi: 10.1177/1090820X10366549.
citation: Kadouch JA. Calcium hydroxylapatite: A review on safety and complications. J Cosmet Dermatol. 2017 Jun;16(2):152-161. doi: 10.1111/jocd.12326. Epub 2017 Mar 1.
citation: Fabi SG, Alhaddad M, Boen M, Goldman M. Prospective Clinical Trial Evaluating the Long-Term Safety and Efficacy of Calcium Hydroxylapatite for Chest Rejuvenation. J Drugs Dermatol. 2021 May 1;20(5):534-537. doi: 10.36849/JDD.5680.
citation: Marmur ES, Phelps R, Goldberg DJ. Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther. 2004 Dec;6(4):223-6. doi: 10.1080/147641704100003048.
citation: Gonzalez N, Goldberg DJ. Evaluating the Effects of Injected Calcium Hydroxylapatite on Changes in Human Skin Elastin and Proteoglycan Formation. Dermatol Surg. 2019 Apr;45(4):547-551. doi: 10.1097/DSS.0000000000001809.
citation: Lapatina NG, Pavlenko T. Diluted Calcium Hydroxylapatite for Skin Tightening of the Upper Arms and Abdomen. J Drugs Dermatol. 2017 Sep 1;16(9):900-906.
citation: Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
citation: Yutskovskaya YA, Kogan EA. Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Decolletage:A Pilot Study. J Drugs Dermatol. 2017 Jan 1;16(1):68-74.
citation: Oranges CM, di Summa PG, Giordano S, Kalbermatten DF, Schaefer DJ. A Changing Paradigm: The Brazilian Butt Lift Is Neither Brazilian Nor a Lift-Why It Needs to Be Called Safe Subcutaneous Buttock Augmentation. Plast Reconstr Surg. 2020 Oct;146(4):502e-503e. doi: 10.1097/PRS.0000000000007200. No abstract available.
citation: Casabona G, Pereira G. Microfocused Ultrasound with Visualization and Calcium Hydroxylapatite for Improving Skin Laxity and Cellulite Appearance. Plast Reconstr Surg Glob Open. 2017 Jul 25;5(7):e1388. doi: 10.1097/GOX.0000000000001388. eCollection 2017 Jul.
citation: Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.