Medical devices · Private label
OrosolCare for
oral mucositis
Relieving pain and burning from 20–30 minutes after the first application, then making eating easier over the course of treatment. Orosol is an oral spray for the treatment of oral mucositis induced by chemotherapy or radiotherapy, in adults and children aged 3 and over. This inflammation of the oral mucosa can cause painful lesions and make meals difficult. Orosol supports oral comfort through local physical action that protects, cleanses and maintains a hydrated environment.
Supplied in a 20 ml, this medical device is applied directly to the oral mucosa by the patient or their caregiver. It offers partners an oncology supportive-care product under their own brand, combining patented technology with documented clinical benefits.
Your oral mucositis product,
under your brand
2 clinical studies
A comparative pilot study and a paediatric placebo-controlled study.
Population
Adults and children aged 3 and over.
Indication
Treatment of oral mucositis associated with chemotherapy or radiotherapy.
Benefits
for patients
- Relieves pain and burning sensations from 20–30 minutes after the first application.
- Immediate action (osmotic mechanical action).
- Reduces difficulty with oral feeding.
- Reduces the severity of oral mucositis.
- Forms a protective film and helps clean the oral mucosa.
- Over 99% naturally derived ingredients.
- Mucocyanidin complex composed of 100% plant-derived ingredients.
Mode of action
Based on our film-forming glycerol technology, Orosol deposits a film on the oral mucosal surface. Three complementary functions act simultaneously.
- Protecting the vulnerable mouth. The film forms a barrier that limits contact with external irritants and helps maintain a hydrated environment.
- Cleaning the mucosa. Osmotic action draws fluids towards the film and facilitates the removal of surface impurities and debris.
- Retaining agents that sustain lesions. Selected polymers capture enzymes involved in tissue degradation within the film, helping reduce their availability at the mucosal surface.
This surface action supports an environment favourable to natural mucosal repair.
Clinical studies · Oral mucositis
Clinical study
Rapid relief of oral discomfort. A comparative, open-label, non-randomised pilot study followed patients aged 7 to 91 with cancer-treatment-related mucositis for 28 days. Of the 69 patients who completed the study, 48 used Orosol and 21 received usual mucositis treatments.
In the Orosol group, 20–30 minutes after the first application, the mean pain score fell from 7.19 to 4.71, a decrease of 34 %, and the burning score from 7.25 to 5.15, a decrease of 29 % compared with baseline. In the comparator group, scores changed from 7.14 to 7.71 and from 6.81 to 6.91, respectively. These scales from 1 to 10 measure symptom intensity, with lower values indicating less discomfort.
Easier feeding and less severe mucositis in children. A randomised, double-blind, placebo-controlled study over 28 days analysed complete data from 21 children aged 3 to 16, including 11 on Orosol and 10 on placebo.
| Benefit observed with Orosol | Time point | Comparison with placebo |
|---|---|---|
| Less difficulty with oral feeding | From day 5 | p = 0.0153 |
| Less severe oral mucositis | From day 7 | p = 0.0122 |
Lower scores reflect easier feeding and less severe mucosal involvement. P-values refer to between-group comparisons at the stated time points, with a significance threshold of 0.05.
Good tolerability observed in the paediatric study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Orosol is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | OS |
| Public name | Orosol |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Adults and children aged 3 and over |
| Category | Oral mucositis |
| Full official indication | Treatment of oral mucositis induced by radiotherapy or chemotherapy |
| Composition | Film-forming glycerol, Mucocyanidin |
| Format / volume | 20 ml oral spray |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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