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Warning: The information provided on this page is for general knowledge purposes only and does not replace the official Instructions for Use (IFU), which are supplied with the medical device. This page does not constitute an electronic IFU either.

OROHEAL : treatment for oral ulcers

OROHEAL is a fast-acting, filmogen liquid bandage that provides relief and promotes healing of mouth ulcers. With its unique triple-action formula, it creates a protective barrier, cleanses the affected area by osmotic action, and supports cellular repair and growth.

This unique formulation is composed of over 99% natural-origin ingredients, ensuring a high-quality product that combines efficacy with excellent safety.

Clinical trial

Randomized, double-blind, placebo-controlled trial

Population

This product is intended for adult use

Indication

Treatment of oral ulcers

Patient's benefits

Fast healing: 60.5% healed in 2 days, 75% in 3 days
Faster than other treatments or no treatment
Rapid symptom relief: pain, burning, and itching reduced within 2–3 days
Easy to use: 74% found it easy to apply
Good taste and texture: rated excellent by 85%
Highly appreciated: 84% rated the product good or excellent
Well tolerated: no serious side effects, mostly non-irritant

Mode of action

Protective Barrier: Forms a protective film on the affected area, shielding it from external contaminants and reducing further irritation. This creates a favorable environment for improved comfort while keeping the lesion hydrated, thanks to the presence of glycerol.
Mechanical Cleaning: Utilizes osmotic action to keep the affected area clean by drawing out excess fluid and removing contaminants, helping to reduce inflammation, swelling, and symptoms.
Cellular Repair: Promotes and accelerates healing and regeneration of the affected area, providing sustained relief while maintaining a favorable environment for improved comfort and supporting the skin's natural healing process.

Clinical Trial

A clinical study involving 48 patients aged 4 to 44 with minor mouth ulcers evaluated the efficacy of Aphtarine®, a 3% Alchemilla vulgaris extract in glycerine. Applied three times daily, the treatment led to complete healing in 60.5% of patients within 2 days and 75% within 3 days, compared to only 10.4% and 33.3% in untreated patients, and 15% and 40% in those using standard treatments. Patients reported rapid relief of pain, burning, and itching symptoms within the first 2–3 days.

The product was well appreciated: 74% found it easy to apply, over 85% rated the taste and texture positively, and 84% considered it a good or excellent treatment. Tolerance was generally good, with no serious adverse effects; 68.2% experienced no irritation, 18.2% reported mild irritation, and 13.6% moderate irritation. The study concluded that Aphtarine® is an effective, safe, and well-accepted treatment for minor mouth ulcers, although it appeared ineffective in cases of herpetiform ulcers.

Product Details

Indication: Used in adults and children (6+) for the treatment of oral ulcers.
Composition: Made from natural-origin ingredients
Presentation: Tube 10ml.
Class: MDR Class IIa.
Age: 18+.
Storage conditions: Below 25°C.
Legal manufacturer: VITROBIO (France).
Product code: AP.