Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

Cellulite Clinical Trial

Official title:

Effects of Calcium Hydroxylapatite on Cellulite Dimples in the Buttocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05885035
• Other study ID #: KD2019
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2023
• Est. completion date: June 26, 2023

Study information

• Verified date: July 2023
• Source: K. Kay Durairaj, MD, FACS, A Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulite

Intervention

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.

Locations

Country	Name	City	State
United States	K. Kay Durairaj, MD, FACS, A Medical Corporation	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Kalpna Kay Durairaj, MD, FACS	Merz North America, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (25)

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.0000000000001 — View 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. — View 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. — View 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 — View 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. — View 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 Ju — View 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. — View 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. — View 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. P — View 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. — View 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. — View 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 — View 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): — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50. — View 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. — View 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 — View 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. — View 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-503 — View 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. Pla — View 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Up to 8 weeks
Secondary	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	Up to 14 weeks
Secondary	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.	Up to 8 weeks
Secondary	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.	Up to 14 weeks
Secondary	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.	Up to 14 weeks
Secondary	Telephone Assessment	Subjects will be contacted weekly to assess safety injection site and treatment responses. Questionnaire will consist of the 5 following questions: How are you feeling?; What (if any) side effects are you experiencing?; Are you experiencing pain as a result of treatment?; Are you following the post-procedural instructions?; Do you have any questions or concerns?	Up to 14 weeks