Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products

Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products

The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.

Safety endpoint: incidence of adverse events.

Study Overview

• Status: Active, not recruiting
• Conditions: Injection Site Reaction
• Intervention / Treatment: Device: Injection

Detailed Description

The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol.

Assessments under this protocol will include ultrasound of in vivo tissue.

Safety endpoint: incidence of adverse events.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Marbella, Spain
    • Ocean Clinic - Av. Ramon y Cajal 7, 29601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male & females; 22 to 65 years of age.
2. Voluntary participation
3. Ability to comprehend and provide informed consent.
4. Participants agree NOT to use any topical agents or products that will induce skin peeling or change the appearance of the skin in the treatment area, during the study period.
5. Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
6. Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
7. Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.

Exclusion Criteria:

1. Any previous surgery in the abdominal area.
2. Any previous treatment in the abdominal area.
3. Planning to receive treatment of any kind in the abdominal area.
4. Acute inflammatory process and/or infection at the injection site.
5. Treatment of skin area with dermatosis.
6. Eczema, exanthema or open wounds.
7. Previous application of over the counter or prescription, oral or topical, anti-wrinkle or skin enhancer products on the abdominal skin within the past 3 months unless allowed by the study and is continued throughout the study.
8. Any contraindication to treatment with biostimulatory products based on the product's IFU.
9. Previous pregnancy or intending to become pregnant during study participation.
10. Known hypersensitivity to biostimulatory products or any of their formulation ingredients.
11. Allergic reaction to topical and local anesthetics.
12. Currently using anticoagulant therapy.
13. Haemophilia / bleeding disorder.
14. Chemotherapy, radiotherapy or high doses of corticosteroids.
15. Systemic infection (e.g., hepatitis).
16. Uncontrolled diabetes mellitus.
17. Any medical condition that may put the participant at increased risk with exposure to biostimulatory products.
18. Any medication that might modulate the immune response.
19. Any other illness or condition that, in the opinion of the investigator, would mean that study participation was not in the best interest of the prospective participant.
20. Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating.
21. Any serious disease or disorder (medical or psychiatric) that could, in the opinion of the investigator, interfere with the safe completion of treatment according to this protocol or with study.
22. Injection of local anesthesia into the flap during abdominoplasty surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Subjects in Arm 1 will receive injections of biostimulatory products (Radiesse, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue.	Device: Injection; A pre specified amount will be injected in tissue at selected timepoints
Experimental: Arm 2; Subjects in Arm 2 will receive injections of 1 of 2 selected biostimulatory products (Radiesse or Sculptra) at 1 timepoint (6 months) prior to removal of redundant abdominal tissue.	Device: Injection; A pre specified amount will be injected in tissue at selected timepoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Analyses	Ultrasound of injection site tissue analyses (dermal thickness (mm), elastosis (mm) and microvascular formation) by PI at various timepoints	6 months, 3 months and 2 weeks prior to surgery timepoint(s)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	Adverse event reporting	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Ann P Marx, MD, Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Extravasation of Diagnostic and Therapeutic Materials; Injection Site Reaction
• Other Study ID Numbers: M900311010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual data will be summarized for analyses

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes