Analysis of Safety and Tissue Interaction of Injectable Biosmulators

Официальное название

Analysis of Safety and Tissue Interaction of Injectable Biosmulators.

Обзор

The goal of this clinical trial is to analyse tissue changes in the pre-auricular region after injectable (Poly-L-Lactic-Acid/Calcium-Hydroxylapatit) biostimulatory interventions in healthy volunteers. The main questions it aims to answer are: How is the Safety Profile of injectable Biostimulatory Treatments? How are the Tissue Interactions after injectable Biostiomulatory Treatments? Participants will: * Recieve one of 2 possible biostumulatory treatments (PLLA/CAHA/ * Attend 4 follow-up appointments after treatment for checkups, surveillance and examinations.

Подробное описание

Regular outclinic patients undergoing biostimulatory treatments will be invited to participate in this study involving photographic evaluations and ultrasound imaging. Following detailed oral and written explanations, patients will provide informed consent.

Participants will be assigned to one of 2 treatment groups:

1. PLLA (Sculptra®, Sinclair Pharmaceuticals) 2. CaHA (Radiesse®, Merz Pharma)

Treatment Protocols:

* PLLA: 1-3 sessions at intervals of 4-6 weeks * CaHA: Single session

These interventions will follow routine clinical protocols, with more frequent follow-ups involving photography and ultrasound imaging as part of the study.

Follow-Up Assessments

Patients will undergo follow-up evaluations at 3 defined time points after treatment:

1. 6 weeks 2. 6 months 3. 12 months

Вмешательства

• Процедура Poly-L-Lactic Acid (Sculptra) injection
  1 to 2 sessions at intervals of 4 to 6 weeks are planned with PLLA (Sculptra®, Galderma Laboratories). PLLA will be injected into the face or neck region using a blunt cannula. For reconstitution, 7 ml of saline solution and 1 ml of 1 % lidocaine will be used. 5 minutes of massaging for 5 times a day are recommended.
• Процедура Calcium Hydroxyapatite
  For CaHA treatment (Radiesse®, Merz Pharma; HarmonyCa®, Allergan), 1 session is planned. The face (cheeks, jawline) or neck will be augmented using a blunt cannula, either diluted (Radiesse® 1:0.2 - 1:2) or undiluted (HarmonyCA®) depending on the product and the region being treated.

Первичные конечные точки

• Inflammatory Reaction [Срок оценки: From enrollment to the end of treatment at 6-8 week]
• Analysis of Injected Biostimulator-Deposits [Срок оценки: From enrollment to the end of treatment at 6 -8 week]
• Tissue Interaction [Срок оценки: From enrollment to the end of treatment at 6-8 weeks]
• Adverse Events [Срок оценки: From enrollment to the end of treatment at 6-8 week]

Вторичные конечные точки (2)

• Clinical Outcome [Срок оценки: From enrollment to the end of treatment at 6-8 week]
• Patient Satisfaction [Срок оценки: From enrollment to the end of treatment at 6-8 week]

Критерии участия

-Inclusion Criteria:

Men and women aged 30 years and older

Good general health, no relevant pre-existing conditions

Patients planning to undergo PLLA or CAHA treatment as part of routine care due to skin laxity or volume loss

Cognitive ability and willingness to provide informed consent

Willingness and ability to attend follow-up visits

-Exclusion Criteria:

Age under 30 years

Pregnant or breastfeeding individuals

Significant open wounds or lesions in the treatment area

Metallic implants in the treatment area

Psychiatric disorders (psychosis, body dysmorphic disorders)

Missing informed consent and/or data privacy declarations

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• University Hospital Hamburg Eppendorf — Hamburg

Публикации

• Wortsman X, Quezada N, Penaloza O, Cavallieri F, Schelke L, Velthuis P. Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid. J Ultrasound Med. 2023 Sep;42(9):2065-2072. doi: 10.1002/jum.16226. Epub 2023 Mar 27. PMID 36972372
• Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 2: Vascular Mapping. Aesthet Surg J. 2021 Oct 15;41(11):NP1633-NP1644. doi: 10.1093/asj/sjaa411. PMID 33954749
• Velthuis PJ, Jansen O, Schelke LW, Moon HJ, Kadouch J, Ascher B, Cotofana S. A Guide to Doppler Ultrasound Analysis of the Face in Cosmetic Medicine. Part 1: Standard Positions. Aesthet Surg J. 2021 Oct 15;41(11):NP1621-NP1632. doi: 10.1093/asj/sjaa410. PMID 33954581
• Wortsman X, Alfageme F, Roustan G, Arias-Santiago S, Martorell A, Catalano O, Scotto di Santolo M, Zarchi K, Bouer M, Gonzalez C, Bard R, Mandava A, Gaitini D. Guidelines for Performing Dermatologic Ultrasound Examinations by the DERMUS Group. J Ultrasound Med. 2016 Mar;35(3):577-80. doi: 10.7863/ultra.15.06046. Epub 2016 Feb 17. PMID 26887446
• Kyriazidis I, Spyropoulou GA, Zambacos G, Tagka A, Rakhorst HA, Gasteratos K, Berner JE, Mandrekas A. Adverse Events Associated with Hyaluronic Acid Filler Injection for Non-surgical Facial Aesthetics: A Systematic Review of High Level of Evidence Studies. Aesthetic Plast Surg. 2024 Feb;48(4):719-741. doi: 10.1007/s00266-023-03465-1. Epub 2023 Aug 10. PMID 37563436
• Pavicic T. Complete biodegradable nature of calcium hydroxylapatite after injection for malar enhancement: an MRI study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:19-25. doi: 10.2147/CCID.S72878. eCollection 2015. PMID 25709485
• Amselem M. Radiesse((R)): a novel rejuvenation treatment for the upper arms. Clin Cosmet Investig Dermatol. 2015 Dec 29;9:9-14. doi: 10.2147/CCID.S93137. eCollection 2016. PMID 26766918
• Yutskovskaya Y, Kogan E, Leshunov E. A randomized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014 Sep;13(9):1047-52. PMID 25226004

Идентификаторы

NCT: NCT06993558 · 2024-101412-BO-ff · University Hamburg Eppendorf

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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