AZFICEL-T, A NEW DRUG FOR NASOLABIAL FOLD WRINKLES IN ADULTS

Produced By: Medical-Reference

CONTENTS Introduction to the Nasolabial folds Available Treatments of the Nasolabial folds What are Dermal fillers? Types of dermal fillers Introduction to Autologous cell therapy Azficel-T: A Revolutionary Autologous Cellular

Product Azficel-T Clinical Trials Advantages of Azficel-T (laViv) over other fillers Processes of Azficel-t (laViv) production Mechanism of Action Dosage of Azficel-T Dosage form and strength Contraindications of Azficel-T Side effects of Azficel-T

Glabellar Lines

PeriorbitalLines

PerioralLines

SmileLines

Worry Lines

Nasolabial Folds

Oral Commissures

Figure 1.Human Facial ExpressionsImage Source: http://t3.gstatic.com/images?q=tbn:ANd9GcQrmEwUk8OJCb_qCDvLrU6HKxRAbBJ18GzttB0GUmuzXfiOK3W-

Introduction to the Nasolabial folds

In human facial features, "smile lines" or "laugh lines" are commonly identified as the nasolabial folds. They begin at the sides of the nose and extend to the sides of the lips. They separate the cheeks from the upper lip.With ageing, these lines may start to turn more permanent and become cosmetically undesirable. Excess skin, skin thinning, excess cheek fat, and ptosis of cheek fat are acknowledged as the most significant factors that contribute to the prominence of the nasolabial folds.

Nasolabial Folds

Figure 2. nasolabial fold marked in black ellipseImage Source: http://upload.wikimedia.org/wikipedia/commons/thumb/7/7e/Nasolabial_fold.jpg/220px-Nasolabial_fold.jpg

AVAILABLE TREATMENTS OF THE NASOLABIAL FOLDSThere are various cosmetic treatments available for the

nasolabial folds and the most common cosmetic treatments are given below:

Anatomical removal Liposuction Dermal filler injections or FaceliftAmong all, dermal filler injections are the most widely used

cosmetic treatment in the present world.

What are Dermal fillers?

Dermal fillers can be defined as the products that are injected or placed into the dermis for to correct facial creases and wrinkles. They are often a kind of soft tissue designed in such a way for purposes of improving the appearance of the skin.

Figure 3. Application of a Dermal FillerImage Source: http://t0.gstatic.com/images?q=tbn:ANd9GcTXN-BRgk9sbHgLU5E9hjxYupAsfFy1XYSC_mCXhLICnaH6Y-jc

TYPES OF DERMAL FILLERS

Various types of dermal fillers are available in the world today. Some of the most common in cosmetic treatments include:

Collagen-based fillers (i.e. Evolence) Hyaluronic acid based fillers (i.e. Restylane and Juvederm) Poly lactic acid based fillers (i.e. Sculptra) and Calcium hydroxylapatite fillers (i.e. Radiesse)

Figure 4. Dermal Fillers are generally used at the above locations of the image

Image Source: www.skinintegrity.com.au

INTRODUCTION TO AUTOLOGOUS CELL THERAPY

Autologous cell therapy (ACT) is principally different from other dermal fillers.

It uses the patient’s own (autologous) fibroblasts for to stimulate collagen and elastin regeneration, and mainly used to correct defects, including wrinkles and scarring. Autologous cell therapy is a natural process that uses the patient’s own cells to fix and restore the skin.

AZFICEL-T: A REVOLUTIONARY AUTOLOGOUS CELLULAR PRODUCT

Azficel-T (laVív) is the first and only adapted autologous cell therapy approved by the FDA for the development of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults.

Azficel-T is intended to present a personalized treatment platform for cosmetic patients in the form of a natural, living cell therapy.

Azficel-T is used to improve the appearance of wrinkles that are seen from the sides of the nose and extend to the sides of the lips. This medicine is harvested from patient’s own skin cells placed in a mixture of water and salts.

Figure 5. A vial of Azficel-TImage Source: http://t1.gstatic.com/images?q=tbn:ANd9GcSLelJsIf9cbQNiHMTe8MWyG65-S-bFhsXeHxTY-kubrpiki7PuPQ

Before

AfterFigure 6. Result of Azficel-T Application

Image Source: beautywithouttheblade.com

AZFICEL-T CLINICAL TRIALS

In clinical trials, Azficel-T (laVív) was well accepted with the common adverse reactions being injection-site reactions that were of mild to moderate intensity and resolved within one week.

The FDA approved clinical trial was based in part on the combined results of two identical Phase III multi-center, randomized, double-blind, placebo-controlled studies of 421 patients.

Azficel-T Clinical Trials

ClinicalStudies

Study One

Study Two

Subject Wrinkle Assessment

Azficel-T Vehicle

57%(57/100)

30%(31/103)

45%(19/108)

18%(19/108)

Physician Wrinkle Assessment

Azficel-T Vehicle

33%(33/100)

7%(7/103)

19%(21/110)

7%(8/108)

Azficel-T Clinical Trials

Table 1. Clinical Trials of Azficel-T

Azficel-T Clinical TrialsIn both studies, the Wrinkle Assessment for the group using

Azficel-T (57%/45%) was considerably improved as compared to the vehicle control group (30%/18%); equally, the Physician Wrinkle Assessment indicated an improvement of the condition using Azficel-T (33%/19% as compared to 7% for both control groups).

ADVANTAGES OF AZFICEL-T (LAVIV) OVER OTHER FILLERS

Azficel-T has two major advantages over other fillers.They are:

1. It stimulate the production of new collagen and elastic fibers

2. It’s totally from natural source

Skin BiopsyUnder local anesthesia small fibroblast samples usually are taken from behind the patient's ear by trained clinicians.

PROCESSES OF AZFICEL-T (LAVIV) PRODUCTION

Image Source: http://www.maxfac.com/facial/images/cfs/61.jpg

PROCESSES OF AZFICEL-T (LAVIV) PRODUCTION

Cell CultureThe sample is then taken to the manufacturer, and

multiplied in culture to produce tens of millions of viable new cells, which are consequently returned via injection to the target skin in the patient.

Around a period of 90 days, hundreds of millions of fibroblasts are prepared and then frozen until required for treatment.

MECHANISM OF ACTION

The actual mechanism of action by which Azficel-T develops the appearance of nasolabial fold wrinkles is still unknown.

DOSAGE OF AZFICEL-T

Inject 0.1 mL ID per linear centimeter into the nasolabial fold wrinkles

This medicine is usually given in 3 doses, spaced 3 to 6 weeks apart

A total of 6 ccs of cellular material given to a patient

DOSAGE FORM AND STRENGTH

Injectable suspension18 million autologous fibroblasts/1.2mL

CONTRAINDICATIONS OF AZFICEL-TAllogeneic useSerious immunological reactions can occur If Azficel-T

is administered to a patient who is not the person whose skin was used to generate the Azficel-T vial.

Severe Hypersensitivity Reactions

Hypersensitivity to the ingredients in Azficel-T can create serious hypersensitivity reactions, including anaphylaxis to the patients

Contraindications of Azficel-T

Active Infection Persons with skin infections in the area where Azficel-T is injected can lead to local or systemic infection

SIDE EFFECTS OF AZFICEL-T

The most common side effects are occurred at the injection-site, including

Redness Bruising Swelling Pain Bleeding Lumps Irritation Itchiness

Rare side effects may include:

Darkening of the skin at the injection site Decreased skin sensation at the injection site Fever Painful cold sores or blisters on the lips Sores, welting, or blisters Swelling or puffiness of the eyelids or face

Side effects of Azficel-T

REFERENCES1. http://www.mylaviv.com/

2. http://www.mayoclinic.com/health/drug-information/DR603475

3. http://reference.medscape.com/drug/laviv-azficel-t-999666

4. http://www.maxfac.com/facial/wrinkles.html

5. www.fibrocellscience.com

6. http://www.drugs.com/nda/azficel_t_091222.html

7. http://beautywithouttheblade.com/2011/07/11/azficel-t-laviv-juvederm-restylane-radiesse-sculptra-dr-nicholas-vendemia-of-mas/

8. http://www.woundsresearch.com/content/autologous-cell-therapy-current-treatments-and-future-prospects

9. http://www.cosmetichealth.net/Non-Surgical-Procedures/Autologous-Cell-Therapy.html

10. http://en.wikipedia.org/wiki/Nasolabial_fold

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