Alma Development, Manufacturing & Licensing of Medical Devices

Medical device effective in the treatment of fissures, cracks and chaps. Recommended also for small rhagades.

Filming polymer able to create a thin protective barrier on areas affected by small wounds, cuts and cracks. It effectively isolates the lesion from the external aggressions and acts by keeping the edges of the wound together, promoting its healing and reducing the pain sensation.

Regulatory status

Medical Device (MDR certified) Class IIa.

Indication

Effective in the treatment of:

Fissures, cracks and chaps of hands and feet caused by external aggressions (cold, friction, aggressive products..)
Recommended also for small rhagades

Ingredients

Its formulation is enriched with:

Nitrocellulose: functional ingredient responsible for the film-forming action. It creates the protective film that covers the lesion and provides the barrier effect of the device.
Methacrylic Copolymer: contributes to the adhesion and persistence of the film on the skin surface (technical function).
Olive Oil: performs a technical function within the formulation by improving spreadability and reducing stringing during application (technical function).

Aspect

Transparent and colorless liquid.
Packed in 7 ml glass bottles.

Claims

Promotes the healing process
Reduces cracks' number, depth, width
Pain reduction
Skin barrier/skin repair

Efficacy test

In vitro test:
barrier effect: -19.4% IL-1α

Clinical evaluation on 20 subjects with hand cracks, comparison with one of the main market leader.
- All parameters measured (cracks’ number, width, length, depth and pain associated to the condition) decreased to day 7 with respect to day 0 in both groups. The test showed that FILMed is as effective as the reference product.

Application

Before application, clean and dry the wound waiting for it to stop bleeding.

Spread the product using the apposite applicator to fill and properly cover the wound. Let it dry for a few seconds. Use 2/3 times a day. In case of need the film can be removed (just apply a drop of FILMED on the already made layer and immediately remove it with a cotton gauze)

Reserved contents

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Filmed