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AtrophyNCT02868749

Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

A study testing Hyaluronic Acid filler in people with Atrophy, run by Vandeputte, Joan, M.D. at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Atrophy
What is being tested?
Hyaluronic Acid filler
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
2 sitesBelgium
Study dates
22 Mar 2017to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Universitair Ziekenhuis Brussel

    Brussels, B-1090

  • A.Z. Oudenaarde

    Oudenaarde, B-9700

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions
Atrophy
Being tested
Hyaluronic Acid filler
Keywords
Hyaluronic Acid, histology, ultrasound, subcutaneous, adipose tissue
Medical subject headings
Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 fillerDevice

    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.

Study groups in NCT02868749
Study groupRoleWhat they receive
Hyaluronic Acid filler 1 for deep injectionExperimentalInjection 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
Receives: Device: Hyaluronic Acid filler
Hyaluronic Acid filler 2 for deep injectionActive comparatorInjection 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
Receives: Device: Hyaluronic Acid filler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tissue inflammation after injection of hyaluronic acid filler

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

    Measured: 3 weeks to 4 months after injection

Secondary outcomes (5)

  1. tissue response after injection of hyaluronic acid filler

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

    Measured: 1 week after injection

  2. tissue response after injection and remodelling of hyaluronic acid filler

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

    Measured: 3 weeks to 4 months after injection

  3. tissue response after injection and remodelling of hyaluronic acid filler

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

    Measured: 1 week after injection

  4. filler distribution in tissue

    The height and width of the total filler spread [mm]

    Measured: 3 weeks to 4 months after injection

  5. filler distribution in tissue

    The height and width of the total filler spread [mm]

    Measured: 1 week after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start22 Mar 2017
  3. Primary completion11 Apr 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02868749
Sponsor's protocol ID
BVL/JVL
Status last verified
Jan 2019
First submitted
27 Jul 2016
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: pilot study on 5 patients: min, max, average measurements will be published

Publications

  • 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.

    PubMed 21272119

  • 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.

    PubMed 16485276

  • 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.

    PubMed 18547183

  • 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.

    PubMed 24077012

  • 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.

    PubMed 26918965

  • 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.

    PubMed 20048624

  • 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.

    PubMed 17519724

  • 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.

    PubMed 24479675

Questions about this trial

What is this clinical trial studying?

A study testing Hyaluronic Acid filler in people with Atrophy, run by Vandeputte, Joan, M.D. at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tissue inflammation after injection of hyaluronic acid filler (time frame: 3 weeks to 4 months after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868749, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.

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