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Varioderm Fine Line
The Varioderm product line is a new generation...
- of highly concentrated and cross-linked hyaluronic acid
- for various indications in the dermis and subcutis
- convincing with long-lasting clinical results
Our objective is a long lasting solution to your face´s ageing process.
As such, we have developed the Varioderm product line as a new generation of injectable hyaluronic acid to restore your youthful appearance.
Each year, thousand of people world-wide receive wrinkle treatments with hyaluronic acid. More than 6 million people have already enjoyed the benefits of this procedure.
Hyaluronic acid is a natural and essential component of the body and is present in many different regions, such as the eyes, joints and skin. With time, hyaluronic acid biogically diminishes resulting in a loss of firmness and the appearance of wrinkles. To fight against these signs of ageing, it is necessary to replace the loss of hyaluronic acid in your skin. This is possible by injecting hyaluronic acid directly in the different layers of the skin tissue.
Hyaluronic acid is a highly biocompatible substance that has been used for many years in several medical applications such as Ophthalmology and Orthopedics.
The Varioderm product line is of non animal origin, no allergy test prior to its use is necessary and contains no anaesthetic or conserving agents.
Each box of
VARIODERM FINE LINE
contains:
- 2 single-use sterile and prefilled 1 ml syringes
- 4 disposable sterile 30G needles
- a packaging insert
- a set of labels with batch numbers for traceability
Keep the product at room temperature between +2C and +25C.
| Concentration | 6 mg / ml |
| Cross-linked | with DVS |
| Injectability | Needle size 30G with excellent visco-elastic features |
| Packaging | 2x 1,0 ml |
| Indications | Superficial to Medium wrinkles Glabella lines Peri-oral and -orbital lines |
| Level of skin | Superficial to Middle dermis |
| Duration | around 3-6 months |
| Injection-Technique | Retro tracing, Criss-cross, Serial points, Fan-Techniques or combination of all above. |
VARIODERM® Indication and Treatment
VARIODERM® products are made of non-animal origin hyaluronic acid. They are medical devices designed to be injected by a doctor experienced specifically in the techniques of filling facial wrinkles by injection in the dermis and subcutaneous tissue.
The area to be treated must be properly cleaned with disinfectant solution before the injection. The treatment is easy and quick. Thanks to its extraordinary visco-elasticity and the use of the thin provided needles, the injections are precise, simple and almost painless. Depending on the sensitivity of the patient, an anaesthesia cream may be appropriate. On certain sensitive areas such as lips, it is recommended to give a local nerve-blocking anaesthesia.
Using enclosed thin needles (between 26-30G) VARIODERM® products can be injected slowly in the mid or deep dermis or subcutaneous tissue by linear withdrawal technique (tunnel or criss-cross technique), by serial puncture- or fan-technique or by a combination of these techniques.
The treated zone must be slightly massaged after injection in order to spread well the implant.
The quantity of VARIODERM® products to be used depends on the depression to fill and the desired effect.
With VARIODERM® products, optimal volume effect is easy to obtain, with less quantity to be injected. No overcorrection is needed. Please read the packing insert for further information.
The area to be treated must be properly cleaned with disinfectant solution before the injection. The treatment is easy and quick. Thanks to its extraordinary visco-elasticity and the use of the thin provided needles, the injections are precise, simple and almost painless. Depending on the sensitivity of the patient, an anaesthesia cream may be appropriate. On certain sensitive areas such as lips, it is recommended to give a local nerve-blocking anaesthesia.
Using enclosed thin needles (between 26-30G) VARIODERM® products can be injected slowly in the mid or deep dermis or subcutaneous tissue by linear withdrawal technique (tunnel or criss-cross technique), by serial puncture- or fan-technique or by a combination of these techniques.
The treated zone must be slightly massaged after injection in order to spread well the implant.
The quantity of VARIODERM® products to be used depends on the depression to fill and the desired effect.
With VARIODERM® products, optimal volume effect is easy to obtain, with less quantity to be injected. No overcorrection is needed. Please read the packing insert for further information.
TREATMENT GUIDELINES
by Doctor A. Alsoufi (Plastic Surgeon – Germany)
These guidelines are useful for plastic surgeons dermatologist, and other aesthetic medicine specialists and physicians who perform facial rejuvenation using fillers.
Informed Consent
Education about the expected outcome and possible complication is essential. In addition to verbal explanations, it is recommended that the patient be given printed material of the Varioderm Filler, a list of what to expect the day of injection, and details of the post injection course. As this a procedure that changes the face in millimeters, it exists the potential for a conflict between the dramatic expectations of the patient and the subtlety of the procedure. It is necessary to inform the patient that cosmetics must not be applied at the implant site for 12 hours following the treatment and not to expose the site direct heat (sun exposure, sauna, solarium... etc.) one to two weeks after injection.
Planning
The author spends a minimum of 20 minutes consultation with patient prior to schedule injection in order to explain the procedure and to find out if any contraindication exists. The author routinely takes more than 2 photographs and views prior to each injection. Pencil tracings of the patient’s face from different angles aid in creating blueprints for planning the injection.
Treatment Guidelines
A/ start every session by cleaning the face with a gentle cleanser and by disinfecting the injection site in order to avoid subsequent infection. Treatment should be postponed if the patient has an incipient or ongoing inflammation or infection in the treatment area.
B/ Varioderm Gel are injected with a thin, sterile needle into the deep dermal layer or in the subcutaneous fat. Varioderm can be injected with a very little discomfort. In order to avoid any discomfort it may be preferable to perform a local or a bloc anesthesia.
C/ in many cases the best results are obtained by using a retrograde, linear technique:
Slowly withdraw the needle while, at the same time, constantly pressing the plunger to deposit thin lines of Varioderm in the tissue, carefully avoiding overcorrection.
Specific indications may require other techniques (micro puncture, multiple layer technique) related to the skin thickness and the concentration of the chosen product. We remind that the average skin thickness is no more than 2mm. In all cases it is important to end the session by massaging the treated area in order to distribute the gel in an even, soft and natural way.
Injection level of VARIODERM products
Adverse Reactions
Side effects are rarely seen, however slight swelling and mild to moderate redness might occur. Few cases of edema have been reported, especially after lips augmentation. Such reactions completely resolve within 2-4 days. In some cases it is recommended to give the patient an anti-inflammatory drug such Diclofenac or Iboprufen. A cold pack can be applied to the injected area to reduce the immediate swelling and discomfort.
Please keep in mind
Varioderm injection must always be performed in the deep dermal level (or subdermal level) According to the high viscosity, high density and cross linking degree, patient needs more less quantity of Varioderm in comparison to other fillers to obtain the same outcome. Approximately 50 % less is required. Clinical and laboratory tests have shown that Varioderm gels have the following clinical, physical and biological characteristics: Varioderm is biocompatible, non toxic, degradable, not absorbable and does not migrate.
by Doctor A. Alsoufi (Plastic Surgeon – Germany)
These guidelines are useful for plastic surgeons dermatologist, and other aesthetic medicine specialists and physicians who perform facial rejuvenation using fillers.
Informed Consent
Education about the expected outcome and possible complication is essential. In addition to verbal explanations, it is recommended that the patient be given printed material of the Varioderm Filler, a list of what to expect the day of injection, and details of the post injection course. As this a procedure that changes the face in millimeters, it exists the potential for a conflict between the dramatic expectations of the patient and the subtlety of the procedure. It is necessary to inform the patient that cosmetics must not be applied at the implant site for 12 hours following the treatment and not to expose the site direct heat (sun exposure, sauna, solarium... etc.) one to two weeks after injection.
Planning
The author spends a minimum of 20 minutes consultation with patient prior to schedule injection in order to explain the procedure and to find out if any contraindication exists. The author routinely takes more than 2 photographs and views prior to each injection. Pencil tracings of the patient’s face from different angles aid in creating blueprints for planning the injection.
Treatment Guidelines
A/ start every session by cleaning the face with a gentle cleanser and by disinfecting the injection site in order to avoid subsequent infection. Treatment should be postponed if the patient has an incipient or ongoing inflammation or infection in the treatment area.
B/ Varioderm Gel are injected with a thin, sterile needle into the deep dermal layer or in the subcutaneous fat. Varioderm can be injected with a very little discomfort. In order to avoid any discomfort it may be preferable to perform a local or a bloc anesthesia.
C/ in many cases the best results are obtained by using a retrograde, linear technique:
Slowly withdraw the needle while, at the same time, constantly pressing the plunger to deposit thin lines of Varioderm in the tissue, carefully avoiding overcorrection.
Specific indications may require other techniques (micro puncture, multiple layer technique) related to the skin thickness and the concentration of the chosen product. We remind that the average skin thickness is no more than 2mm. In all cases it is important to end the session by massaging the treated area in order to distribute the gel in an even, soft and natural way.
Injection level of VARIODERM products
Adverse Reactions
Side effects are rarely seen, however slight swelling and mild to moderate redness might occur. Few cases of edema have been reported, especially after lips augmentation. Such reactions completely resolve within 2-4 days. In some cases it is recommended to give the patient an anti-inflammatory drug such Diclofenac or Iboprufen. A cold pack can be applied to the injected area to reduce the immediate swelling and discomfort.
Please keep in mind
Varioderm injection must always be performed in the deep dermal level (or subdermal level) According to the high viscosity, high density and cross linking degree, patient needs more less quantity of Varioderm in comparison to other fillers to obtain the same outcome. Approximately 50 % less is required. Clinical and laboratory tests have shown that Varioderm gels have the following clinical, physical and biological characteristics: Varioderm is biocompatible, non toxic, degradable, not absorbable and does not migrate.
IMPLANTATION TESTS
Experimental and Biocompatibility Studies demonstrated the long duration and safety of Varioderm products. Histological studies show 3 months and 7 months duration of VARIODERM® Subdermal in rats skin:
Figure 1
Capsule of VARIODERM® implant in rat, at low magnification. The broad capsule consists of a meshlike connective tissue (reddish), which includes many small encapsulated gel particles (A) (stained blue). On the bottom right, there is subcutaneous fat tissue. (B)
Figure 2
VARIODERM® Subdermal: 7 months after injection in rat hypodermis (magnification x10). Meshlike connective tissue (reddish) includes many small encapsulated gel particles (stained in blue). No inflammatory reaction is observed (no giant multinucleated cells, no macrophages).
Experimental and Biocompatibility Studies demonstrated the long duration and safety of Varioderm products. Histological studies show 3 months and 7 months duration of VARIODERM® Subdermal in rats skin:
Figure 1
Capsule of VARIODERM® implant in rat, at low magnification. The broad capsule consists of a meshlike connective tissue (reddish), which includes many small encapsulated gel particles (A) (stained blue). On the bottom right, there is subcutaneous fat tissue. (B)
Figure 2
VARIODERM® Subdermal: 7 months after injection in rat hypodermis (magnification x10). Meshlike connective tissue (reddish) includes many small encapsulated gel particles (stained in blue). No inflammatory reaction is observed (no giant multinucleated cells, no macrophages).
Comparison of durability with other HA-fillers to VARIODERM® Comparative kinetic study demonstrates the advantage of VARIODERM®: up to twice more volume is observed at the same time after only one injection.
HIGHEST CROSS LINKED HYALURONIC ACID WORLDWIDE
The previous manufacturing methods generate hyaluronic acids of various qualities: more or less diluted monophasic solutions or suspension of particles. However, the traditional processes for obtaining hyaluronic acid do not achieve the optimal durability after injection in the skin. This is why ADODERM GmbH has chosen to develop a new generation of hyaluronic acid with a longer durability in the skin.
Purification
Hyaluronic acid contained in VARIODERM® products is obtained by bio-fermentation. After extended cross linking process the obtained gel will be purified.
Particulisation and Homogenisation
The highly concentrated and cross linked hyaluronic acid, which has a significantly higher viscosity compared to the initial mixture, is subsequently formed into particles and stabilized, without need of any dilution. This method is described as the new "Monophasic Particle Technology” (MPT).
Sterilisation and Final Packaging
After filling, glass syringes are sterilised and packaged into blister containers. Then, syringes, packaging insert, traceability labels and needles are enclosed into the box.
Test and Final Release
Before release, all tests (sterilisation, bacterial endotoxin, pH-value, etc.) are carried out according to European Pharmacopoeia and international standards.
HIGHEST CROSS LINKED HYALURONIC ACID WORLDWIDE
The previous manufacturing methods generate hyaluronic acids of various qualities: more or less diluted monophasic solutions or suspension of particles. However, the traditional processes for obtaining hyaluronic acid do not achieve the optimal durability after injection in the skin. This is why ADODERM GmbH has chosen to develop a new generation of hyaluronic acid with a longer durability in the skin.
Purification
Hyaluronic acid contained in VARIODERM® products is obtained by bio-fermentation. After extended cross linking process the obtained gel will be purified.
Particulisation and Homogenisation
The highly concentrated and cross linked hyaluronic acid, which has a significantly higher viscosity compared to the initial mixture, is subsequently formed into particles and stabilized, without need of any dilution. This method is described as the new "Monophasic Particle Technology” (MPT).
Sterilisation and Final Packaging
After filling, glass syringes are sterilised and packaged into blister containers. Then, syringes, packaging insert, traceability labels and needles are enclosed into the box.
Test and Final Release
Before release, all tests (sterilisation, bacterial endotoxin, pH-value, etc.) are carried out according to European Pharmacopoeia and international standards.
 |
Hyaluronic Acid (106 Daltons) Solution between 6-27mg/ml Extended cross linking process Particularisation Ho |
FREQUENTLY ASKED QUESTIONS
How long do the results last?
VARIODERM® persists in the dermis for at least 3 to 18 months. The high degree of cross-linking supports a slower resorption of VARIODERM® in the tissue. The durability of VARIODERM® in the skin varies according to skin type, age and the way of life of the patient as well as treated area and injection technique. It can be necessary to renew the treatment partially in order to optimize the results and durability of the correction.
Are there any precaution measures to be undertaken?
How long do the results last?
VARIODERM® persists in the dermis for at least 3 to 18 months. The high degree of cross-linking supports a slower resorption of VARIODERM® in the tissue. The durability of VARIODERM® in the skin varies according to skin type, age and the way of life of the patient as well as treated area and injection technique. It can be necessary to renew the treatment partially in order to optimize the results and durability of the correction.
Are there any precaution measures to be undertaken?
- After the injection, it is recommended to apply ice or a cooling device on the treated areas in order to decrease the transitory inflammation due to injection.
- Make-up should be avoided during the first twelve hours following the injection.
- The client must also avoid saunas, steam bath, UV rays and exposure to cold during 10 days following the injection.
- In the event of prolonged exposure to the sun, a sun block should be applied to the treated areas.
Are there contra-indications?
VARIODERM® should not be used on pregnant women or breast feeding. It should not be injected in a patient presenting an auto-immune disease, antecedents of allergy or over-sensitiveness to the hyaluronic acid, or a immuno-therapeutic treatment. VARIODERM® should not be injected into inflammatory and/or infectious skin (acne, herpes, impetigo…), skin prone to develop hypertrophic scars. It should not be used in conjunction with any laser treatment, chemical peeling or dermabrasion. A prior consultation with the patient will enable you to know the medical history, especially previous aesthetic treatments (like injections) and to determine if VARIODERM® is suitable to this individual case. For more information please refer to the packaging insert of VARIODERM®.
Are there undesirable effects?
As with all skin fillers swelling and/or redness, with or without associated pain, may occur after the injection. These generally disappear within a few hours, days or in some cases within a week. Some rare cases of necrosis, abscess, granuloma or of over-sensitivity have been described in the scientific literature after injections of hyaluronic acid. Continuation of these reactions or appearance of any other side effects must be reported to the practitioner by the patient as soon as possible in order to resolve it by appropriate treatment. The distributor should also be informed about this incident. Before treatment, please inform the patient about the potential side effects related to this injectable implant.
