EvolutHA · Caromed Italia · manufactured by Italfarmacia s.r.l., Rome
Injectable medical device · intradermal
Two formulations with hyaluronic acid and amino acids for intradermal microinjection. EvolutHA also contains choline, EvolutHA X antioxidants. Here you can see what sets them apart, and what the instructions for use say about how to use them.
What it is
According to the instructions for use, EvolutHA and EvolutHA X are a filling and modelling solution for the dermal matrix: a sterile, pyrogen-free, injectable medical device for intradermal microinjection that is slowly degraded after implantation.1,2 Both are based on hyaluronic acid and amino acids. The difference lies in what they contain in addition.
Sodium hyaluronate is the base of both formulations.
Glycine, L-serine, L-alanine, L-proline, L-lysine and L-cysteine. EvolutHA X also contains L-leucine and L-valine.
Choline bitartrate is part of the composition.
Reduced glutathione and sodium ascorbyl phosphate are part of the composition.
The composition is taken from the manufacturer’s instructions for use.1,2
The range
Both are supplied as 3 × 5 ml vials, with an implant card and self-adhesive labels for traceability.
Comparison
The table is based on the instructions for use.1,2
| EvolutHA | EvolutHA X | |
|---|---|---|
| Based on | Hyaluronic acid, amino acids and choline | Hyaluronic acid, amino acids and antioxidants |
| Choline | Yes, choline bitartrate | No |
| Antioxidants | No | Yes, reduced glutathione and sodium ascorbyl phosphate |
| Amino acids | Glycine, L-serine, L-alanine, L-proline, L-lysine, L-cysteine | Glycine, L-serine, L-alanine, L-proline, L-lysine, L-cysteine, L-leucine, L-valine |
| Indication | Prevention and treatment of skin and epidermal damage such as pigmentation and dehydration | Prevention and treatment of skin damage caused by free radicals, and treatment of skin damage such as pigmentation and dehydration |
| Administration | Intradermal microinjection into the superficial layers of the dermis | Intradermal microinjection into the superficial layers of the dermis |
| Dose and interval | Max. 5 ml per treatment session, one session every 30 days | Max. 5 ml per treatment session, one session every 30 days |
| Supplied as | 3 × 5 ml vials | 3 × 5 ml vials |
| Basic UDI-DI | 805571533ITF00493 | 805571533ITF0038Z |
The full composition, contraindications and side effects are listed in the instructions for use for each product.
How to choose
The method of use is the same. The choice of product is the practitioner’s clinical judgement, in line with the instructions for use.1,2
EvolutHA
The formulation with choline. Indicated for the prevention and treatment of skin and epidermal damage such as pigmentation and dehydration.1
EvolutHA X
The formulation with antioxidants. Indicated for the prevention and treatment of skin damage caused by free radicals, and the treatment of skin damage such as pigmentation and dehydration.2
Use
The steps below are an excerpt. Read the full instructions for use before the first treatment.1,2
1
2
3
Dose and interval1,2
Before you treat
Excerpt from the instructions for use.1,2 See the instructions for use for the full list of contraindications, precautions and side effects.
Questions and answers
Both are based on hyaluronic acid and amino acids. EvolutHA also contains choline. EvolutHA X instead contains the antioxidants reduced glutathione and sodium ascorbyl phosphate, and has a broader indication that also covers skin damage caused by free radicals.
EvolutHA is indicated for the prevention and treatment of skin and epidermal damage such as pigmentation and dehydration. EvolutHA X is indicated for the prevention and treatment of skin damage caused by free radicals, and for the treatment of skin damage such as pigmentation and dehydration.
By intradermal microinjection into the superficial layers of the dermis, after thorough disinfection of the treatment area. The maximum dose is 5 ml per treatment session, with one session every 30 days. Only qualified medical personnel may administer the products.
Not at the same time. The instructions for use state that the products must not be used at the same time as chemical peels, laser or dermabrasion.
Among other things, not in blood vessels, in case of infection or inflammation in the treatment area, or in pregnant or breastfeeding women and children. See the instructions for use for the full list.
Yes. EvolutHA and EvolutHA X are CE-marked medical devices with notified body 0373. The manufacturer is Italfarmacia s.r.l., Rome, under the Caromed Italia brand.
Each pack contains an implant card and self-adhesive labels. The summary of safety and clinical performance (SSCP) is available in Eudamed under the product’s Basic UDI-DI.
Prices and ordering for verified clinics.
