CONJONCTYL® is a sterile aqueous solution of sodium monomethyltrisilanol orthohydroxybenzoate associating a bioavailable organic silicon derivative and salicylic acid.
CONJONCTYL® has an identical formula and all the qualities associated with this formula. CONJONCTYL® is a medical device now available in pharmacies in a new indication filling skin depressions (frown lines, crow's feet) and scars by intradermal injections.
Over the years, several authors have referred to CONJONCTYL ®, particularly in the field of aesthetic medicine. Preclinical studies in our research unit and a rigorous clinical study confirmed the efficacy of this product in aesthetic medicine.
The active substance is CONJONCTYL ® salicylate monomethyltrisilanol. It is not the mineral silica, but an organic compound of silicon, because of the presence of silicon-carbon bonds (Si-C) forming the part monomethyltrisilanol. Salicylate and silanol parts are linked by hydrogen bonds. These are links that allow the maintenance of the product in solution and avoid the polycondensation of monomethyltrisilanol. Product is overwhelmingly present in the form of monomers and at maximum as trimères.Une when injected into the dermis, there is a rupture of the hydrogen bonds and separation of the two parts of the molecule. The analgesic action of salicylate reduces pain due to injection. The release of in situ silanol and potentiates its action in the reorganization of the dermis.
CONJONCTYL ®, presented in a box of 10 vials of 5 ml, is marketed as a medical device in its new indication filling depressions skin wrinkles (brow, crows feet) and scars intradermiques.CONJONCTYL ® injections is why in full compliance with the requirements of Directive 93/42 for Class III medical devices. As an injectable product, so it is perfectly sterile and non-pyrogenic. His new plastic packaging bottles assures his seal, so its sterility, and enhances its stability over time.
SILICON 'If' functional partner of the skin
Connective tissues, including the dermis, are characterized by the presence of a large extracellular matrix consisting primarily of proteoglycans and glycosaminoglycans, collagen fibers and elastine, and structural glycoproteins. These components are organized precisely to form a three dimensional network (supramolecular organization) that confers the mechanical properties to such fabrics. However, it is recognized that the silicon 'If' is a bridging of these components of connective tissue via siloxane bonds (Si-O-Si) and its presence influences the stereo-structure.
Unlike fillers commonly used in skin depressions, 'If' provided by CONJONCTYL ® will then act on the reorganization of the architecture of the connective tissue. So we applied to demonstrate that the original concept is effective.
Pre-clinical study
We evaluated the effect of CONJONCTYL ® on the supramolecular arrangement of the extracellular matrix during skin aging in the hairless rat and the influence of CONJONCTYL ® on the evolution of the structural organization of the dermis. For this, a young, untreated control rats than 6 months, is compared with that of two lots of rats aged 17 months, a treated group and untreated lot.
The treated rats received at the age of 12 months, a daily topical application of CONJONCTYL ®, 5 days per week for 5 months. The results showed that collagen and elastin are organized interfibrillary areas are maintained and conservation of the dermis was observed. We thus find a structural organization of the dermis very close to that of a 6 months old skin!
Clinically proven efficacy
A multicenter clinical trial designed to demonstrate the effect of the filling CONJONCTYL ® skin depressions, especially wrinkles, has been achieved. This study focused on two groups of 50 female volunteers receiving intradermal injections CONJONCTYL ® during three sessions one week apart in 1-3 areas of the face (crow's feet and / or intersourcilière area).
The evaluation of efficacy was:
- Using an image processing fingerprints taken before, then 3 and 9 weeks after the last injection CONJONCTYL ®
- Through macrophotographies taken the first day of the test, then 9 weeks after the last injection
- Using a set from the scores given by the volunteers themselves VAS assessment.
Skin impressions show a statistically significant improvement in skin texture wrinkles sitting on the thick skin at the furrow between the eyebrows. Meanwhile, the perception of a voluntary filling, whatever the treated area was maintained for six months in 40% of volunteers and for one year in 35% of volunteers. This set of experimental and clinical data helps to demonstrate the functionality of CONJONCTYL ® targeting the reduction of skin depressions, especially wrinkles, and the persistence of treatment effects.
Ease of administration
In the clinical study presented earlier, two intradermal injection techniques were tested separately and in combination for wrinkles crow's feet and furrows between the eyebrows: serial puncture and rétrotraçage. The results are similar.
Technique for serial puncture, needle 4 mm long and 3.5 / 10 mm diameter were used. Injections points were spaced 2 to 3 mm, 2 mm deep for about 0.1 ml volumes leading to the formation of tiny papules.
For technical rétrotraçage, needles 13 mm long and 3/10 mm (type 27 or 30G) were used. The use of this type of syringe is indeed authorized by the fluidity of the solution CONJONCTYL ®. Once the needle is inserted parallel to the skin, the product should be injected very slowly when removing the needle. This allows both to control the amount injected and the correction made, and make it more comfortable injection to the patient. The injected volumes were variable depending on the ride but usually between 0.25 and 0.40 mm per site.
For both techniques, it is also possible, while maintaining the dimensions described above, attached directly compatible disposable sterile needles on Luer neck of the bulb.
Whatever intradermal injection mode selected, the product should be administered at room temperature, and in all cases should never be frozen, as this can cause irreversible polymerization of salicylate silanol.
The injection pain is highly variable and can be reduced by applying a local anesthetic before injection.
Excellent tolerance = safety
CONJONCTYL ® was marketed between 1973 and 1996 to over 24 million bulbs. During this period, there has been no reported case of pharmacovigilance. As in the past when CONJONCTYL ® was administered intravenously and intramuscularly, CONJONCTYL ® has demonstrated its perfect intradermal local and general tolerance. CONJONCTYL ® also has a good allergy tolerance.
Availability
CONJONCTYL ® is marketed as a medical device in its new indication filling depressions skin wrinkles (brow, crows feet) and scars by intradermal injections.
CONJONCTYL ® is in full conformity with the requirements of Directive 93/42 for Class III medical devices.
As an injectable product, so it is perfectly sterile and non-pyrogenic. His new plastic packaging bottles assures sterility and improves its stability over time ..
CONJONCTYL ®, presented in a box of 10 vials of 5 ml, is distributed in France through a network of pharmacies.
For other countries, thank you to contact directly Sedifa LABORATORY
Storage: Do not freeze the bulbs.
Réf. : 7709523003066