Lipogel Medical Device for Atopic Skin

Since 2024, our lipogel medical device for atopic skin has been MDD certified

The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices in Europe. Thanks to the extension of deadlines, devices compliant with the MDD Directive may continue to be marketed until December 31, 2027 for Class III and Class IIb implantable devices, and until December 31, 2028 for Class IIb, IIa, and I devices.

We have obtained the extension of the MDR transitional period beyond May 26, 2024 for our legacy Class I, IIa, and III devices, confirming compliance with MDR through submission of certification applications to the notified body. We have also signed an agreement with the notified body to ensure continued market availability and regular surveillance of each legacy device.

The well-being of sensitive, atopic or dermatitis-prone skin is a clinical priority that requires targeted, effective, and well-tolerated solutions. Our Class I DILCOIL lipogel medical device, developed with a formula rich in natural functional ingredients, is designed to provide intensive treatment for the symptoms of atopic-prone skin, eczema, xerosis, dermatitis, and hyper-reactive skin.

Thanks to its emollient and protective texture, it creates a barrier film on the skin’s surface, helping to restore epidermal function, deeply hydrate the skin, improve elasticity, and relieve itching, pain, and burning.

DILCOIL LIPOGEL – Functional ingredients and benefits

The dilcoil lipogel is formulated with a synergistic combination of highly skin-compatible active ingredients, selected for their effectiveness on irritated, dehydrated, and inflamed skin:

• Melatonin (high bioavailability): regenerating, antioxidant, and rebalancing action on skin microbiota
• Sweet almond oil, rice bran oil, oat oil: emollient, moisturizing, and elasticity-enhancing
• Shea butter, Bisabolol: soothing effect on itching and redness
• Vitamin E, Tocotrienols, Tocopheryl acetate: antioxidant protection
• Ceramide 3: strengthens the skin barrier and prevents water loss
• 7-Dehydrocholesterol: vitamin D precursor, helps restore epidermal function
• Beeswax, Silica, Polyurethane-79: form a gentle, non-occlusive protective barrier

Intended use and target population

The DILCOIL lipogel is indicated for:

• Atopic and eczema-prone skin
• Dermatitis (atopic, contact, seborrheic)
• Xerotic, dehydrated and fragile skin
• Intolerant and hyper-reactive epidermis
• Intensive symptomatic treatment of acute and recurrent phases of atopic dermatitis
• Prevention and treatment of skin lesions due to epidermal barrier dysfunction

Its tolerability makes it suitable for all ages, including children and elderly people, and it is particularly useful for long-term topical treatments, with no risk of irritation or sensitization.

A protective, reparative and soothing lipogel

Thanks to its balanced lipid formulation, our medical device provides:

• Protective action: forms a barrier film that shields the epidermis
• Restorative action: helps restore the skin barrier’s function
• Soothing action: relieves itching, pain, and burning sensation
• Moisturizing and rebalancing: restores skin elasticity and homeostasis

Ideal as dermatological support, both as a stand-alone treatment and in combination with pharmaceutical therapies.

In addition to offering a line of MDD-certified medical devices for atopic skin, we are specialized manufacturers of medical devices, with solid experience in developing solutions for sensitive, reactive and dermatitis-prone skin. Thanks to our internal know-how, we provide market-ready products and create custom formulations in private label and contract manufacturing, offering tailored responses to the specific needs of each customer.

Innovation, quality and safety are at the heart of our work, to deliver effective, well-tolerated and customized dermatological solutions.