NCT02868749

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

July 27, 2016

Last Update Submit

January 22, 2019

Conditions

Atrophy

Keywords

Hyaluronic Acidhistologyultrasoundsubcutaneousadipose tissue

Outcome Measures

Primary Outcomes (1)

  • tissue inflammation after injection of hyaluronic acid filler

    Presence of lymphocytes and/ or histiocytes around the filler through histologic examination \[Yes/No\]

    3 weeks to 4 months after injection

Secondary Outcomes (5)

  • tissue response after injection of hyaluronic acid filler

    1 week after injection

  • tissue response after injection and remodelling of hyaluronic acid filler

    3 weeks to 4 months after injection

  • tissue response after injection and remodelling of hyaluronic acid filler

    1 week after injection

  • filler distribution in tissue

    3 weeks to 4 months after injection

  • filler distribution in tissue

    1 week after injection

Study Arms (2)

Hyaluronic Acid filler 1 for deep injection

EXPERIMENTAL

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

Hyaluronic Acid filler 2 for deep injection

ACTIVE COMPARATOR

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

Interventions

Hyaluronic Acid fillerDEVICE

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.

Hyaluronic Acid filler 1 for deep injectionHyaluronic Acid filler 2 for deep injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitair Ziekenhuis Brussel

Brussels, B-1090, Belgium

Location

A.Z. Oudenaarde

Oudenaarde, B-9700, Belgium

Location

Related Publications (8)

  • Flynn TC, Sarazin D, Bezzola A, Terrani C, Micheels P. Comparative histology of intradermal implantation of mono and biphasic hyaluronic acid fillers. Dermatol Surg. 2011 May;37(5):637-43. doi: 10.1111/j.1524-4725.2010.01852.x. Epub 2011 Jan 27.

    PMID: 21272119BACKGROUND

  • Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronic acid induced Tyndall effects. Lasers Surg Med. 2006 Mar;38(3):202-4. doi: 10.1002/lsm.20283.

    PMID: 16485276BACKGROUND

  • Arlette JP, Trotter MJ. Anatomic location of hyaluronic acid filler material injected into nasolabial fold: a histologic study. Dermatol Surg. 2008 Jun;34 Suppl 1:S56-62; discussion S62-3. doi: 10.1111/j.1524-4725.2008.34244.x.

    PMID: 18547183BACKGROUND

  • Micheels P, Sarazin D, Besse S, Sundaram H, Flynn TC. A blanching technique for intradermal injection of the hyaluronic acid Belotero. Plast Reconstr Surg. 2013 Oct;132(4 Suppl 2):59S-68S. doi: 10.1097/PRS.0b013e31829a02fb.

    PMID: 24077012BACKGROUND

  • Franca Wanick FB, Almeida Issa MC, Luiz RR, Soares Filho PJ, Olej B. Skin Remodeling Using Hyaluronic Acid Filler Injections in Photo-Aged Faces. Dermatol Surg. 2016 Mar;42(3):352-9. doi: 10.1097/DSS.0000000000000659.

    PMID: 26918965BACKGROUND

  • Shaw RB Jr, Katzel EB, Koltz PF, Kahn DM, Girotto JA, Langstein HN. Aging of the mandible and its aesthetic implications. Plast Reconstr Surg. 2010 Jan;125(1):332-342. doi: 10.1097/PRS.0b013e3181c2a685.

    PMID: 20048624BACKGROUND

  • Rohrich RJ, Pessa JE. The fat compartments of the face: anatomy and clinical implications for cosmetic surgery. Plast Reconstr Surg. 2007 Jun;119(7):2219-2227. doi: 10.1097/01.prs.0000265403.66886.54.

    PMID: 17519724BACKGROUND

  • Pilsl U, Rosmarin W, Anderhuber F. The premaxillary space: a location for filler injection? Dermatol Surg. 2014 Mar;40(3):301-4. doi: 10.1111/dsu.12431. Epub 2014 Jan 30.

    PMID: 24479675BACKGROUND

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Joan H Vandeputte, MD

    A.Z Oudenaarde (Oudenaarde General Hospital)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 16, 2016

Study Start

March 22, 2017

Primary Completion

April 11, 2018

Study Completion

September 30, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

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

Locations

BE(2)