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

开始日期2023-01-01

申办/合作机构

Merz North America, Inc.

IRCT20210712051854N2 / Recruiting临床3期IIT

Triple blind evaluation of the efficacy of oral calcium Hydroxy-apatite on post-operative pain, grip and bone mineral density after distal radius fracture surgery

开始日期2022-03-21

申办/合作机构-

100 项与 Calcium Hydroxyapatite 相关的临床结果

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100 项与 Calcium Hydroxyapatite 相关的转化医学

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100 项与 Calcium Hydroxyapatite 相关的专利（医药）

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项与 Calcium Hydroxyapatite 相关的文献（医药）

2024-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour

Article

作者: Dakovic, Rada ; Moradi, Amir

SummaryWhat is this article about? A study (ClinicalTrials.gov identifier: NCT03583359) that tested whether an injectable filler treatment called calcium hydroxylapatite with lidocaine, or CaHA (+), could improve the shape of the jawline.How was the study in this summary conducted? Loss of jawline shape is a change to jawline appearance, like sagging or deflating, that occurs as people get older. A total of 123 participants received CaHA (+) injections on day 1 of the study (immediate treatment). Fifty-seven participants did not receive CaHA (+) until week 12 (delayed treatment). Jawline shape at week 12 was rated on a five-point scale (0 = no loss of shape or volume; 4 = extreme loss). Researchers also looked at participants' satisfaction and self-reported improvement, ratings of how old participants thought they looked, and side effects.What were the results of the study? In the immediate treatment group, 76% of participants had improvement in jawline shape at week 12 (compared with 9% of participants in the delayed treatment group), which typically lasted approximately 8 months, and 94% self-reported improvement in jawline appearance. The participants were more satisfied with their jawlines and reported looking approximately 3 years younger at week 12 compared with before treatment. Regardless of sex or skin tone, side effects were categorized as mostly mild or moderate reactions, like lumps or bruising, at the site where CaHA (+) was injected.What do the results of this study mean? The results showed that CaHA (+) injections improved jawline shape in most participants and caused only mild or moderate side effects regardless of sex or skin tone, suggesting that CaHA (+) is safe and works well for diverse groups of patients.Who should read this article? This summary is for patients and others interested in learning about how CaHA (+) works, its safety, and its ability to improve jawline shape.Who sponsored this study? The study was sponsored by Merz North America, Inc.

2024-10-01·DERMATOLOGIC SURGERY

Clinical and Histological Effects of Calcium Hydroxyapatite Filler in the Orofacial Region: A Study in Rats

Article

作者: Payeras, Márcia Rodrigues ; Cherubini, Karen ; Thums, Marianna Ávila ; Koth, Valesca Sander ; Salum, Fernanda Gonçalves

BACKGROUND:

Calcium hydroxyapatite (CaHA) dermal filler has been increasingly used in facial aesthetic procedures.

OBJECTIVE:

To investigate clinical and histological changes associated with calcium hydroxyapatite (CaHA) dermal filler in the orofacial region.

MATERIALS AND METHODS:

Forty-eight female Wistar rats were divided into CaHA and control groups. The material was applied in the ventral tongue and the submandibular region; the animals were euthanized after 7, 30, and 90 days.

RESULTS:

After 7 days, yellowish nodules with a firm consistency were observed on the tongue. In 2 animals, the material migrated to the base of the tongue. Histopathological examination revealed CaHA spheres surrounded by an infiltrate, predominantly composed of macrophages. In the CaHA group, the percentage of collagen in the tongue and dermis was higher compared with the control group (p < .05) at both 30 and 90 days. The thickness of the epidermis/dermis was also higher in the CaHA group (p < .05). In 5 submandibular glands containing material, areas of edema and hyperemia were observed, along with infiltrates of neutrophils, lymphocytes, and plasma cells. Changes in the morphology of ducts and acini in adjacent regions were evident.

CONCLUSION:

CaHA exhibits satisfactory properties for filling and collagen biostimulation in the tested regions. Further studies are required to explore the potential for migration and the glandular alterations.

2024-10-01·Journal of Cosmetic Dermatology

Long‐term duration and safety of Radiesse (+) for the treatment of jawline

Article

作者: Martinez, Keith ; Durkin, Alan J. ; Nasrallah, Nicole ; Del Campo, Roberta ; Green, Jeremy B. ; Funt, David K. ; Moradi, Amir

Abstract:

Background:

Calcium hydroxyapatite (CaHA)‐carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long‐term follow‐up of a randomized, multicenter, rater‐blinded trial reports efficacy and safety of CaHA‐CMC(+) through 48 and up to 60 weeks post‐treatment.

Methods:

Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA‐CMC(+) injections in both jawlines. While touch‐ups were permitted 4 weeks post‐treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1‐point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48‐week data from the combined treatment and control/delayed groups and 60‐week data for the treatment group.

Results:

Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post‐treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA‐CMC(+)‐related events that were mostly resolved and overwhelmingly mild.

Conclusions:

CaHA‐CMC(+) produced clinically meaningful and long‐lasting improvements in jawline contour and was well tolerated in patients through 60 weeks.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03583359.

项与 Calcium Hydroxyapatite 相关的新闻（医药）

2023-11-06

·PRNewswire

Designs for Health Launches Innovative Probiotic Toothpaste, PerioBiotic™ Silver

Leading supplement brand debuts the only probiotic toothpaste suitable for sensitive teeth PALM COAST, Fla., Nov. 6, 2023 /PRNewswire/ -- Designs for Health, the expert-recommended and preferred brand for high-quality, professional strength, research-backed supplements, and recipient of the 2023 Top Nutraceutical Company award ** today announced the launch of PerioBiotic™ Silver, a fluoride-free probiotic toothpaste formulated with a unique combination of ingredients to support tooth enamel strength, brighten your smile, and support overall oral health.* This product joins Designs for Health's growing line of oral health solutions including PerioPull™ and Periommune™. PerioBiotic™ Silver features Kalident, a nano-hydroxyapatite, purified silver, CoQ10, grape seed extract, and Dental-Lac™, a strain of Lactobacillus paracasei. Dental-Lac™ has been shown in clinical research to help support a healthy balance of bacteria in the mouth and overall periodontal health.* Similar to the role of probiotics in the gastrointestinal tract, beneficial oral bacteria may help maintain dental and oral health. Purified silver may support overall oral wellness, CoQ10 may help support gum health, and grape seed extract may help healthy inflammatory support.* Two unique functional ingredients in this formula are calcium hydroxyapatite and hydrated silica. Hydroxyapatite is the primary mineral component of healthy tooth enamel, which can be worn down over time by acidic foods and drinks, harsh orthodontic glues and braces, and microbial imbalances within the mouth. Incorporating calcium hydroxyapatite into one's daily routine may help promote healthy tooth enamel and overall shine. Hydrated silica may possess natural cleaning properties and promote the teeth's natural brightness. Additionally, instead of using traditional harsh sulfates, this formula contains coco betaine, a coconut-sourced foaming and cleansing agent, and is suitable for sensitive teeth. "Since fluoride was added to toothpaste in the 1950s, not much has changed in the way of true innovation in the toothpaste category, which is why we are thrilled to announce the launch of our unique PerioBiotic™ Silver formulation," said Founder and Chairman Jonathan Lizotte at Designs for Health. "The latest science shows a healthy mouth begins with a balanced oral microbiome, which is why we have meticulously formulated it to exclude harsh irritants, toxins, and foaming and whitening agents that could compromise one's oral health. The final product is a culmination of clinically studied ingredients based on the latest research to help design a healthier smile for all." Designs for Health began in 1989 as a small educational services company with deep roots in natural medicine – and big ambitions to revolutionize the industry. More than 30 years later, the company is pioneering new approaches to nutritional science, breaking barriers in quality standards, and ultimately transforming the healthcare ecosystem. Through a robust product pipeline and a diverse portfolio of more than 300 nutritional products, Designs for Health is leading the charge in the natural and integrative medicine movement to design a well world for all. PerioBiotic™ Silver contains no fluoride, sodium lauryl sulfate, or saccharin. It is free of BPAs, parabens, synthetic colors, gluten, dairy, and synthetic sweeteners, and is vegetarian and non-GMO. It comes in spearmint and lemon flavors and is available to purchase at . To learn more about Designs for Health and its comprehensive portfolio of products, including its line of oral health products, visit . Please tune in to Designs for Health's new podcast, Conversations for Health, and immerse yourself in the current landscape of Functional Medicine to empower you to design a well world with us. About Designs for Health, Inc. Family-owned Designs for Health, Inc. offers high-quality dietary supplements and functional foods to healthcare professionals and their patients. Guided by its founding philosophy of "Science-First™," the company holds an unwavering commitment to creating research-driven formulations with meaningful quantities of functional ingredients that maximize the potential for successful health outcomes. For over 30 years, Designs for Health has been many healthcare professionals' trusted source for not only product innovation but also leadership in clinical education and practice development solutions. *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. **Top Nutraceutical Company awarded by Food Business Review Contact: 5WPR 212-999-5585 [email protected] SOURCE Designs for Health

2023-07-18

·drugs

Fluoride Toothpaste, Make Room for a New Competitor

TUESDAY, July 18, 2023 -- Fluoride may have found its match in preventing cavities. New research shows that toothpaste containing hydroxyapatite, one of the main mineral components in teeth, can prevent cavities as effectively as fluoride, which has been used in toothpaste since 1956. The findings were published July 18 in Frontiers in Public Health . “If the article is correct based on the data, one might choose the hydroxyapatite over the fluoride, because the hydroxyapatite itself is safer than fluoride,” said Dr. Leonard Patella , a dentist with Northwell Health in Glen Cove, N.Y., who was not involved with the study. “If you give too much fluoride, it can be toxic. And too much fluoride, if ingested, can cause damage to teeth. It can cause something called fluorosis.” Dental fluorosis is a condition that changes the appearance of tooth enamel and can happen when children consume fluoride during their teeth-forming years. In places like the United States, cases are typically fairly mild and usually result in white or brown spots on the teeth. In more severe cases, however, pits can form. “This is a very important issue,” said researcher Dr. Elżbieta Paszyńska , head of the department of integrated dentistry at Poznań University of Medical Sciences in Poland. “Unlike fluorides, hydroxyapatite has a high remineralization effect, biocompatibility, and is safe if accidentally swallowed. Dentists worldwide should be informed about hydroxyapatite to be a safe and efficient alternative to fluorides for daily oral care.” For their research, her team enlisted 171 patients in an 18-month trial, with an aim that none would have an increase in cavities by the study's end. Patients were evenly split, half brushing twice per day with hydroxyapatite toothpaste and half brushing twice per day with fluoridated toothpaste. They were asked to brush at the same time every day with an electric toothbrush. They had a dental exam every six months. At the end of the trial, 89.3% of the hydroxyapatite group and 87.4% of the fluoride group had no new cavities. Both toothpastes worked equally well, the findings showed. But whether hydroxyapatite will steal fluoride's crown for most popular mineral in dental health remains to be seen. Caries, the beginning of tooth decay, are the result of bacteria attacking the surface of the tooth, said Dr. Janet Moradian-Oldak , a professor of dentistry and biosciences/bioengineering at the University of Southern California. “When you eat too much sugar, the bacteria uses the sugar, metabolizes it, and then creates acid, and that acid dissolves the enamel of the tooth," she explained. "And if you don't have good dental hygiene, if you eat acidic food, if you don't brush your teeth, and if dissolving the mineral is faster than rebuilding the mineral in your saliva, that eventually leads to cavity." Fluoride basically slows demineralization, Moradian-Oldak said. “They’re basically protecting the tooth from dissolving too fast," she explained, adding "this is the cheapest way to prevent progression of dental caries.” Hydroxyapatite toothpaste, on the other hand, is more expensive, a Google search shows. Prices range from $11 to $18 for hydroxyapatite toothpaste and between $2 to $5 for fluoride toothpaste. It’s also worth noting that this study looked only at dental caries, and not how hydroxyapatite affects more severe issues like cavities. But, for people who are anti-fluoride, this could be the ideal alternative, Patella said. “There are a lot of patients, kids, parents who say we don't want fluoride, so they use non-fluoridated toothpaste — and by itself, non-fluoridated toothpaste is not as effective in protecting the teeth,” he said. “You're cleaning the teeth, you're removing the plaque, but you're not protecting the teeth, making them stronger as it happens with fluoride. So in this case, if someone is completely against fluoride, and now they have an alternative that could prevent children from getting cavities, I think it's a great solution.” Sources Elżbieta Paszyńska, DDS, MSC, PhD, head, department of integrated dentistry, Poznań University of Medical Sciences, Poznań, Poland Janet Moradian-Oldak, MSc, PhD professor, dentistry, and professor, biomedical sciences and bioengineering, University of Southern California, Los Angeles Leonard Patella, DDS, chairman, dental medicine, Northwell Health Glen Cove Hospital, Glen Cove, N.Y. Frontiers in Public Health , July 18, 2023 Posted July 2023

临床结果

100 项与 Calcium Hydroxyapatite 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Calcium Hydroxyapatite	-	DBSALT002431

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
脂肪团	临床1期	美国	Merz North America, Inc.	2023-01-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05885035 (Pubmed \| Dermatol Surg)	临床1期	-	25	Injected Calcium Hydroxylapatite	淵觸製壓簾製鬱憲鬱積(齋窪築艱鹽壓壓鏇築選) = 衊壓鏇鬱顧壓築鬱鹽夢壓積餘遞鏇選壓廠鹽齋 (顧膚糧顧鹽憲艱淵觸襯 ) 更多	-	2019-04-01