Clinical trial NCT06093815: 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
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Reaction
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Injections will be in redundant abdominal tissue scheduled to be removed at end of study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound Analyses
timeFrame: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Secondary outcomes:
Other outcomes:
measure: Safety Assessment
timeFrame: through study completion, an average of 6 months
Locations:
city: Marbella
country: Spain
facility: Ocean Clinic - Av. Ramon y Cajal 7, 29601
Study officials:
affiliation: Merz North America, Inc.
name: Ann P Marx, MD
role: STUDY_DIRECTOR
References: