- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868749
Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue
Comparative Clinical, Histological and Ultrasound Pilot Study of Two Hyaluronic Acid Gel Fillers, Designed for Deep Injection, in Adipose Tissue
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussel, Belgium, B-1090
- Universitair Ziekenhuis Brussel
-
Oudenaarde, Belgium, B-9700
- A.Z. Oudenaarde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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.
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 |
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.
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Joan H Vandeputte, MD, A.Z Oudenaarde (Oudenaarde General Hospital)
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BVL/JVL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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