Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

NCT05885035 | Completed Phase 1 FDA Drug

• 1 other identifier: KD2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Cellulite

Keywords

Buttocks; Calcium hydroxylapatite; Hyperdilution; Hyperdiluted calcium hydroxylapatite; Minimally invasive; Gluteal augmentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Global Aesthetic Improvement Scale (GAIS) Rating

  Up to 8 weeks

• Global Aesthetic Improvement Scale (GAIS) Rating

  Up to 14 weeks

• Cellulite Severity Scale (CSS) Rating

  Up to 8 weeks

• Patient Satisfaction of Aesthetic Appearance

  Up to 14 weeks

• Patient Treatment Satisfaction

  Up to 14 weeks

Study Arms (1)

Treated with hyperdilute Calcium Hydroxylapatite (CaHA)

EXPERIMENTAL

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

Interventions

Calcium Hydroxyapatite DRUG

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.

Treated with hyperdilute Calcium Hydroxylapatite (CaHA)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females, 21-50 years old, of any race and ethnic background.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kalpna Kay Durairaj, MD, FACS: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

K. Kay Durairaj, MD, FACS, A Medical Corporation

Pasadena, California, 91105, United States

Location

Related Publications (26)

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  PMID: 31044123 RESULT

• 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.

  PMID: 30358631 RESULT

• 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.

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• 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.

  PMID: 25610523 RESULT

• 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.

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• 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.

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• 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.

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  PMID: 26505542 RESULT

• 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.

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  PMID: 24301235 RESULT

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  PMID: 26056483 RESULT

• 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.

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  PMID: 28247924 RESULT

• 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.

  PMID: 33938688 RESULT

• 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.

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• 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.

  PMID: 30893178 RESULT

• 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.

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  PMID: 20480786 RESULT

• 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.

  PMID: 28095536 RESULT

• 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.

  PMID: 32639431 RESULT

• 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.

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  PMID: 19220646 RESULT

• Durairaj K, Baker O, Yambao M, Linnemann-Heath J, Shirinyan A. Safety and Efficacy of Diluted Calcium Hydroxylapatite for the Treatment of Cellulite Dimpling on the Buttocks: Results from an Open-Label, Investigator-Initiated, Single-Center, Prospective Clinical Study. Aesthetic Plast Surg. 2024 May;48(9):1797-1806. doi: 10.1007/s00266-023-03815-z. Epub 2024 Jan 22.

  PMID: 38253886 DERIVED

MeSH Terms

Conditions

Cellulite

Interventions

Durapatite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Study Officials

• Kalpna K Durairaj, MD

  K. Kay Durairaj, MD, FACS, A Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: January 1, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)