RECRUITING

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin

Conditions

Photoaging Extracellular matrix Hyaluronic acid dermal filler

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.

Official Title

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin

Quick Facts

Study Start:2024-05-09

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06195605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects must understand and sign the informed consent prior to participation * Subjects must be in generally good health * Subjects must be able and willing to comply with the requirements of the protocol	* Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy * Individuals with bleeding disorders * Tend to heal poorly or form very thick scars called keloids * Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction. * Individuals with active inflammation or infection of the skin, including active herpes infection. * Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection. * History of allergies to gram positive bacterial proteins * Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks. * Have an active inflammation or infection of the skin near the site of injection * Are taking any medications that suppress your immune system * Have severe allergies to medications or other things that we believe might make participation unsafe for you * Have a history of connective tissue diseases, such as: * rheumatoid arthritis * scleroderma * polymyositis/dermatomyositis * systemic lupus erythematosus (SLE)

Inclusion Criteria

Exclusion Criteria

* Subjects must understand and sign the informed consent prior to participation
* Subjects must be in generally good health
* Subjects must be able and willing to comply with the requirements of the protocol

* Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
* Individuals with bleeding disorders
* Tend to heal poorly or form very thick scars called keloids
* Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
* Individuals with active inflammation or infection of the skin, including active herpes infection.
* Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
* History of allergies to gram positive bacterial proteins
* Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
* Have an active inflammation or infection of the skin near the site of injection
* Are taking any medications that suppress your immune system
* Have severe allergies to medications or other things that we believe might make participation unsafe for you
* Have a history of connective tissue diseases, such as:
* rheumatoid arthritis
* scleroderma
* polymyositis/dermatomyositis
* systemic lupus erythematosus (SLE)

Contacts and Locations

Study Contact

Diane Fiolek

CONTACT

734-763-1469

dianemch@med.umich.edu

Principal Investigator

Gary Fisher

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Gary Fisher, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-09

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-05-09

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Extracellular matrix
Hyaluronic acid
dermal filler

Additional Relevant MeSH Terms

Photoaging