Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02868749
• Other study ID #: BVL/JVL
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: Vandeputte, Joan, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 30, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrophy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	A.Z. Oudenaarde	Oudenaarde

Sponsors (2)

Lead Sponsor	Collaborator
Vandeputte, Joan, M.D.	Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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. — View Citation

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. — View Citation

França 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. — View Citation

Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronic acid induced Tyndall effects. Lasers Surg Med. 2006 Mar;38(3):202-4. — View Citation

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. — View Citation

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. — View Citation

Rohrich RJ, Pessa JE. The fat compartments of the face: anatomy and clinical implications for cosmetic surgery. Plast Reconstr Surg. 2007 Jun;119(7):2219-27; discussion 2228-31. — View Citation

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):332-42. doi: 10.1097/PRS.0b013e3181c2a685. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]	1 week after injection
Secondary	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]	3 weeks to 4 months after injection
Secondary	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]	1 week after injection
Secondary	filler distribution in tissue	The height and width of the total filler spread [mm]	3 weeks to 4 months after injection
Secondary	filler distribution in tissue	The height and width of the total filler spread [mm]	1 week after injection