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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, and supports cellular repair and growth. Clinical studies show 60% complete healing within 48 hours and 75% healing within 2 to 3 days.

Clinical trial

Randomized, double-blind, placebo-controlled trial

Population

This product is intended for adult use

Indication

Treatment of oral ulcers

Overview


ORAL ULCERS, a filmogen liquid bandage specifically designed for the treatment of mouth ulcers. This product comes in a handy 10ml tube, making it easy to apply and carry around.


Mode of action


Our product works by targeting pro-inflammatory proteins, contaminants, and impurities. It has three main actions:

 

Protective Barrier Effect:

The product forms a protective layer over the ulcer, shielding it from further irritation or damage. This barrier allows the ulcer to heal in a secure and clean environment.

 

Osmotic and Cleaning Effect:

The product helps to draw out fluid from the ulcer, reducing swelling and promoting faster healing. It also helps to clean the ulcer, removing impurities that could potentially cause infection.

 

Cellular Repair and Growth Effect:

The product promotes the repair and growth of cells in the affected area, accelerating the healing process.




Clinical Trial


Participants: The study included 48 healthy male and female patients aged between 4 and 44 years, presenting minor mouth ulcers.

Treatment: The product used was Aphtarine®, a 3% extract of Alchemilla vulgaris in glycerine, applied topically to the ulcers three times a day (t.i.d.).

Healing Time:

  • 60.5% of patients experienced complete healing within 2 days.
  • 75% of patients experienced complete healing within 3 days.
  • Compared to untreated patients, 10.4% healed within 2 days and 33.3% within 3 days.
  • Patients using commonly available treatments saw 15% healing within 2 days and 40% within 3 days.

Symptom Relief: Patients reported significant relief from discomfort within the first 2-3 days. The study highlighted the rapid reduction of pain, burning, and itching sensations associated with mouth ulcers.

Product Appreciation:

  • Ease of application: 73.9% of patients found Aphtarine® very easy or easy to apply.
  • Taste and texture: Over 85% of patients rated the taste and texture as good or excellent.
  • Overall impression: 84% of patients rated the product as a good or excellent treatment for mouth ulcers.

Safety:

  • Aphtarine® was well-tolerated locally, with no significant adverse effects reported.
  • 68.2% of patients found it non-irritant, while 18.2% reported slight irritation, and 13.6% reported moderate irritation.

Conclusion: Aphtarine® is a promising new treatment for healing common mouth ulcers, demonstrating significant efficacy, safety, and patient satisfaction. However, it was noted that the product did not benefit two patients with herpetiform ulcers, suggesting it may not be effective for all ulcer types.



See full publication (PDF)

 



Product Details


  • Indication: Filmogen liquid bandage for the treatment of oral ulcers.
  • Composition: Filmogenic glycerol, xanthan gum, honey, water, association of Vaccinium macrocarpon and Vaccinium myrtillus.
  • Presentation: Tube 10ml.
  • Class: MDR Class IIa.
  • Direction: Apply to wounds, 2-3 times a day.
  • Precautions: The product is intended for topical use (oral cavity) only. Keep out of reach and sight of children.
  • Age: 18+.
  • Storage conditions: Below 25°C.
  • Legal manufacturer: VITROBIO (France).
  • Product code: AP.