Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

January 22, 2019 updated by: Vandeputte, Joan, M.D.

Comparative Clinical, Histological and Ultrasound Pilot Study of Two Hyaluronic Acid Gel Fillers, Designed for Deep Injection, in Adipose Tissue

This study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA), designed for deep injection, that have been used for several years on a worldwide scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a Wise pattern skin excision (inverted T inframammary scar) Informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked.

Participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery.

In each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface.

Both sessions will be monitored by ultrasound examination. After the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection.

At the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination.

The objective of the histologic examination is to assess the tissue response at one week versus three weeks to four months after the injection, as well as to assess the spread of the products, with and without remodelling after injection.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, B-1090
        • Universitair Ziekenhuis Brussel
      • Oudenaarde, Belgium, B-9700
        • A.Z. Oudenaarde

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients eligible for and requesting abdominoplasty
  • patients eligible for and requesting bilateral breast reduction

Exclusion Criteria:

  • Patients prone to hypertrophic scarring or keloids
  • Hypersensitivity to hyaluronic acid
  • Hypersensitivity to lidocaine or amide type local anaesthetics
  • Autoimmune disease
  • Severe, multiple allergies or anaphylactic shock
  • Epilepsy
  • Heart rhythm disorders
  • Porphyria, congenital methemoglobinemia, glucose-6 phosphate dehydrogenase deficiencies, treatment with methaemoglobin-inducing substances.
  • Previous streptococcal disease (acute rheumatic fever whether or not with heart valve involvement)
  • Patients on medication which slows hepatic metabolism (such as cimetidine, beta-blockers)
  • Diabetes requiring insulin treatment
  • Major system disease.
  • Coagulation disorders. Anticoagulation therapy. Chronic use of acetylsalicylic acid.
  • Previous surgery in the areas eligible for injections.
  • All contraindications to their surgical treatment (such as pregnancy or lactation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic Acid filler 1 for deep injection

Injection Session 1 of Hyaluronic Acid filler 1, 3 weeks to 4 months before the surgery

Injection Session 2 of Hyaluronic Acid filler 1, 5 to 9 days before the surgery
Device: Hyaluronic Acid filler
Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in one side of the abdomen or one breast, 3 weeks to 4 months before the surgery.
Device: Hyaluronic Acid filler
Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in other side of the abdomen or other breast, 5 to 9 days before the surgery.
Active Comparator: Hyaluronic Acid filler 2 for deep injection

Injection Session 1 of Hyaluronic Acid filler 2, 3 weeks to 4 months before the surgery

Injection Session 2 of Hyaluronic Acid filler 2, 5 to 9 days before the surgery
Device: Hyaluronic Acid filler
Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in one side of the abdomen or one breast, 3 weeks to 4 months before the surgery.
Device: Hyaluronic Acid filler
Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in other side of the abdomen or other breast, 5 to 9 days before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue inflammation after injection of hyaluronic acid filler
Time Frame: 3 weeks to 4 months after injection
Presence of lymphocytes and/ or histiocytes around the filler through histologic examination [Yes/No]
3 weeks to 4 months after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue response after injection of hyaluronic acid filler
Time Frame: 1 week after injection
Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No]
1 week after injection
tissue response after injection and remodelling of hyaluronic acid filler
Time Frame: 3 weeks to 4 months after injection
Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No]
3 weeks to 4 months after injection
tissue response after injection and remodelling of hyaluronic acid filler
Time Frame: 1 week after injection
Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No]
1 week after injection
filler distribution in tissue
Time Frame: 3 weeks to 4 months after injection
The height and width of the total filler spread [mm]
3 weeks to 4 months after injection
filler distribution in tissue
Time Frame: 1 week after injection
The height and width of the total filler spread [mm]
1 week after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vandeputte, Joan, M.D.

Collaborators

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Joan H Vandeputte, MD, A.Z Oudenaarde (Oudenaarde General Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

April 11, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVL/JVL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

pilot study on 5 patients: min, max, average measurements will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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