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Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products

Primary Purpose

Injection Site Reaction

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Injection
Sponsored by
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Injection Site Reaction

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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). Uncontrolled diabetes mellitus. Any medical condition that may put the participant at increased risk with exposure to biostimulatory products. Any medication that might modulate the immune response. 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. Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating. 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. Injection of local anesthesia into the flap during abdominoplasty surgery.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ultrasound Analyses
Ultrasound of injection site tissue analyses (dermal thickness (mm), elastosis (mm) and microvascular formation) by PI at various timepoints

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 17, 2023
Sponsor
Merz North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06093815
Brief Title
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
Official Title
Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Reaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Injections will be in redundant abdominal tissue scheduled to be removed at end of study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Injection
Intervention Description
A pre specified amount will be injected in tissue at selected timepoints
Primary Outcome Measure Information:
Title
Ultrasound Analyses
Description
Ultrasound of injection site tissue analyses (dermal thickness (mm), elastosis (mm) and microvascular formation) by PI at various timepoints
Time Frame
6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Other Pre-specified Outcome Measures:
Title
Safety Assessment
Description
Adverse event reporting
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). Uncontrolled diabetes mellitus. Any medical condition that may put the participant at increased risk with exposure to biostimulatory products. Any medication that might modulate the immune response. 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. Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating. 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. Injection of local anesthesia into the flap during abdominoplasty surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann P Marx, MD
Phone
984-233-3816
Email
ann.marx@merz.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann P Marx, MD
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ocean Clinic - Av. Ramon y Cajal 7, 29601
City
Marbella
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela R Casabona, MD
Phone
+34 951 77 55 18
Email
grcasabona@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual data will be summarized for analyses

Learn more about this trial

Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products

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