Projekt je sufinancirala Europska unija iz Europskog fonda za regionalni razvoj
Naziv projekta: Certifikacijom biljnih medicinskih proizvoda tvrtke Apiherbal d.o.o. do tržišta, oznaka KK.032.1.12.0082
Razdoblje provedbe Projekta: od 01.lipnja 2020. do 01.lipnja 2021. godine
BIOAPIFIT®ANTI ATOPIC OINTMENT
Bioapifit® anti atopic ointment is a medical device of risk class IIa based on the ingredients of the herbal and honeybee origin. The product does not contain synthetic based preservatives, dyes or fragrances.
Composition Composition (INCI): Glycerin, Prunus Amygdalus Dulcis oil, Mel (certified organic), Cera flava, Helichrysum italicum flower extract, Nigella sativa seed oil, Oenothera biennis oil, Argania spinosa kernel oil, Theobroma Cacao, Calendula officinalis flower extract, Matricaria chamomilla flower extract, Lavandula officinalic flower extract, Achillea millefolium extract, Salvia officinalis extract, Plantago major leaf extract, Olea europaea leaf extract, Melaleuca alternifolia leaf oil, Thymus vulgaris ct. Thymol oil, Origanum vulgaris oil.
Intended use: BioapifitÒ anti atopic ointment is intended for adult population of both genders and children older than 12 years of age to help relieve the signs/symptoms like dry skin, impaired epidermal barrier function, itching, flaking, burning, redness, increase in skin pH associated with chronic, non-infectious inflammatory skin disorders such as atopic dermatitis, seborrheic dermatitis, neurodermatitis, perioral dermatitis, psoriasis vulgaris, psoriasis erythrodermica, lichen planus I.
Mode of action: Thanks to the ingredients with hydrating, humectant, emollient, soothing, pH-adjusting and coating effect, the ointment creates a protective layer on the damaged skin that alleviates the symptoms of the non-infectious inflammatory skin diseases by preventing the contact of pathogens and allergens with the damaged skin barrier and preventing trans-epidermal water loss and, consequently, skin drying. Furthermore, the ointment promotes the restoration of epidermal barrier function by optimizing skin hydration, preventing trans-epidermal water loss, and lowering skin pH toward a healthy range. The product removes the scaly surface of the skin by the emollient action of macerates and vegetable oils. The humectant, soothing and emollient effect of glycerin and honey in the combination with vegetable oils and oil macerates relieves flaking, burning, redness and itching.
Instructions for use: Apply the ointment onto affected parts of the skin 5-6 times a day. Duration of the treatment depends on the type of disease and severity of the symptoms. The product may be used for 28 consecutive days.
Packaging: A tube containing 50 mL of the ointment in a cardboard box.
Precautions: BioapifitÒ anti atopic ointment is not suitable for infants and children under age of 12. Do not use in case of hypersensitivity to any of the product ingredients. Avoid contact with eyes. Do not eat, do not swallow. In case of swallowing contact your doctor. In case of accidental contact with eyes rinse with plenty of water.
Storage instructions: Keep in a dark place, at temperature not exceeding 25oC, out of the reach of children.
Manufacturer: APIHERBAL d.o.o., Dubrava 124, 10040 Zagreb, Croatia
Summary of the clinical investigation results: Following 28 days of the treatment of the patients with Psoriasis vulgaris with Bioapifit anti atopic ointment resulted with decrease of total PASI score between 82.2 and 99.4% (91.5±4.9%). In the end of the treatment the total PASI score decreased from the baseline value of 32.8±13.1 to 2.9±1.2. The clinical cure defined as more than 90% decrease of total PASI score was observed in 70% of the patients while other 30% of the cases were classified as clinical improvement.
Following the treatment of the patients with atopic dermatitis with Bioapifit anti atopic ointment the total SCORAD index decreased from 35.9±15.0 to 3.3±4.6. Following the treatment with Bioapifit anti atopic ointment the extent of the disease score was reduced for 85.5%, the disease intensity parameters were decreased between 85.8% and 100% and the score presenting subjective symptoms showed 100% decrease while the total SCORAD index was reduced for 95%. The clinical cure rate was 80%.
The treatment of the patients with seborrheic dermatitis with Bioapifit anti atopic ointment showed 100% decrease of the scores for scales or crusts as well as itching while the scores for skin flakes, redness and total score dropped for 87.5%, 91.7% and 94.7% respectively. The clinical cure rate was 80%.
None of the patients experienced any adverse effect (worsening of the existing symptoms, appearance of new symptoms, irritation or allergic reaction) during the treatment and follow up period.
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