Karisma RH Collagen Face 1x2ml
Important Notice
Medical device regulated by the European Medical Device Regulation (MDR), intended exclusively for authorized healthcare professionals. By purchasing, the customer declares to be authorized for their professional activity; false information may entail legal responsibilities.
KARISMA FACE Rh Collagen® from Taumedika is a biorestorative soft filler combining high-molecular-weight hyaluronic acid, carboxymethylcellulose and an alpha-1 R-polypeptide chain of human type I collagen obtained by recombinant technology in transgenic silkworm. This α1 chain acts as a direct precursor in the fibroblast's endogenous collagen synthesis, not as filling material.
- Active α1 R-polypeptide chain of human collagen
- Vehicle high-molecular-weight HA + CMC
- Contents 1 syringe × 2.0 ml
- Needles 2 × 27G ½"
- Protocol T0 · T30 · 4 months
Composition and technology
Composition according to the manufacturer: high-molecular-weight hyaluronic acid with the addition of the alpha-1 R-polypeptide chain of collagen and carboxymethylcellulose.
- α1 R-polypeptide chain of human type I collagen (Rh Collagen): patented technology. The hydroxylated α1 chain is synthesised by a transgenic silkworm, which secretes it into the cocoon from the gene sequence of the α1 chain of human collagen. It shows 99.9 % similarity to the human chain, a size of 100 kDa and 100 % solubility; its monofilament structure makes it immediately bioavailable.
- High-molecular-weight hyaluronic acid: stabilises, protects and hydrates the extracellular matrix and orients the collagen fibres.
- Carboxymethylcellulose (CMC): excipient of non-animal and non-bacterial origin. According to the manufacturer it inhibits hyaluronidase and slows the action of the matrix metalloproteinases responsible for the degradation of type I collagen.
Mechanism: the α1 chain stimulates the synthesis of the C-propeptide of type I procollagen in the fibroblast and facilitates the winding of the procollagen triple helix. The effect is biostimulating and tightening; the product is not designed as a projection volumiser.
The manufacturer does not publish the quantitative concentrations of the three components in its leaflet.
Indications and treatment areas
Indication: medium-term correction of facial skin defects due to skin ageing and/or volume loss. The manufacturer also envisages the treatment of acne scars and of states of cutaneous atrophy.
Treatment areas: facial wrinkles, nasolabial fold, perioral wrinkles, cheekbones, lips and chin.
It must not be injected into the periorbital region (eyelids, crow's feet) or into the glabellar and frontal region, in accordance with the contraindications in the product leaflet. Do not inject into blood vessels, muscles or tendons, nor for breast augmentation.
Technique and treatment protocol
Protocol under physiological ageing-prevention conditions:
- Point technique and linear retrograde technique
- Plane: mid dermis (rarely deep)
Protocol in aged skin:
- Linear retrograde technique
- Plane: mid and deep dermis
- Session scheme: T0 and T30 — two sessions 30 days apart. The manufacturer emphasises that this interval is relevant because it follows cell turnover, which occurs approximately every 28 days.
- Maintenance: repetition of the treatment or of the complete protocol at 4 months.
- Session duration: approximately 30 minutes, depending on the area treated.
- Volume per session: 1 pre-filled syringe of 2 ml.
- Inject at room temperature and under strict aseptic conditions. After injection, massage the treated area to ensure uniform distribution of the product.
- Do not mix the product with other products. Do not overcorrect.
Technical data
| Manufacturer | Taumedika S.r.l., Via Monte Giberto 33, 00138 Rome (Italy) |
|---|---|
| Active ingredient | α1 R-polypeptide chain of human type I collagen (recombinant) |
| Origin of the active | Synthesis in transgenic silkworm from the human gene sequence; 99.9 % similarity, 100 kDa |
| Other components | High-molecular-weight hyaluronic acid, carboxymethylcellulose |
| Anaesthetic | Not included |
| Presentation | 1 pre-filled glass syringe of 2.0 ml, 2 needles of 27G ½" and package leaflet |
| Sterilisation | Ethylene oxide |
| Injection plane | Mid and deep dermis |
| Classification | Class III injectable medical device |
| Use | Qualified healthcare professionals only |
Storage and pack contents
- The pack includes: 1 pre-filled glass syringe of 2.0 ml, 2 needles of 27G ½" and the package leaflet.
- Storage: between 2 °C and 25 °C, in a dry place and in the original packaging, protected from direct sunlight and heat sources. Do not freeze.
- The contents of the pre-filled syringe are sterile; the outer surface of the syringe is not.
- Do not use if the packaging is open or damaged, or after the stated expiry date.
- Single-use product. Do not re-sterilise. After use it must be disposed of immediately in accordance with current regulations.
Contraindications and warnings
Contraindications: do not inject into the periorbital region (eyelids, crow's feet) or the glabellar-frontal region; do not inject intravascularly; known individual hypersensitivity to the product or to any of its substances; vascular collagen disorders and autoimmune connective tissue diseases; active infection or inflammation in the area to be treated; epilepsy not controlled with medical treatment; tendency to hypertrophic scars; porphyria; patients under 18 years of age. Its use is not recommended during pregnancy and breastfeeding, although no specific contraindications are known.
Combinations: do not use in immediate association with laser treatment, deep chemical peeling or dermabrasion. After a superficial peel, do not inject if the inflammatory reaction produced is significant.
Warnings: apply the usual precautions for intradermal infiltrations. As with any percutaneous treatment there is a risk of infection. A slight stinging sensation may occur, disappearing within a few minutes, as may oedema and erythema associated with the trauma of the injection, resolving spontaneously in the following hours. The injection point must be located on healthy skin.
Always consult the leaflet enclosed in the packaging before application.
Medical device intended exclusively for qualified healthcare professionals. Technical information based on the manufacturer's official documentation (KARISMA FACE Rh Collagen® product leaflet, Taumedika S.r.l.). This data sheet does not replace the instructions for use accompanying the product.
