Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products

NCT06093815 | Completed FDA Device

• 1 other identifier: M900311010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Injection Site Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Assessment

  through study completion, an average of 6 months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Interventions

Injection DEVICE

A pre specified amount will be injected in tissue at selected timepoints

Arm 1; Arm 2

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male \& females; 22 to 65 years of age.
• Voluntary participation
• Ability to comprehend and provide informed consent.
• 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.
• Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
• Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
• Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.

You may not qualify if:

• Any previous surgery in the abdominal area.
• Any previous treatment in the abdominal area.
• Planning to receive treatment of any kind in the abdominal area.
• Acute inflammatory process and/or infection at the injection site.
• Treatment of skin area with dermatosis.
• Eczema, exanthema or open wounds.
• 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.
• Any contraindication to treatment with biostimulatory products based on the product's IFU.
• Previous pregnancy or intending to become pregnant during study participation.
• Known hypersensitivity to biostimulatory products or any of their formulation ingredients.
• Allergic reaction to topical and local anesthetics.
• Currently using anticoagulant therapy.
• Haemophilia / bleeding disorder.
• Chemotherapy, radiotherapy or high doses of corticosteroids.
• Systemic infection (e.g., hepatitis).

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (1)

Ocean Clinic - Av. Ramon y Cajal 7, 29601

Marbella, Spain

Location

MeSH Terms

Conditions

Injection Site Reaction

Interventions

Injections

Condition Hierarchy (Ancestors)

Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ann P Marx, MD

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Injections will be in redundant abdominal tissue scheduled to be removed at end of study

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 23, 2023
• Study Start: September 8, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)