Use of Novox oil in the management of angular cheilitis
| ISRCTN | ISRCTN26092754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26092754 |
- Submission date
- 12/02/2021
- Registration date
- 24/02/2021
- Last edited
- 14/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Angular cheilitis (AC) is a disease characterized by ulcers at the corner of the lips, forcing patients, especially children, to lick their lips. Clinically, it is characterized by redness, cracks in the skin, ulcers, and crusting of the lip corners and the surrounding skin, either in one corner of the mouth or both. There are several different causes of AC and recurrence of the disease. Infection of the skin by two microorganisms: Candida albicans and Streptococcus aureus, have been associated with the disease.
Antifungal treatments have been suggested as treatments but there is not much scientific evidence to show that this treatment is reliable. Access to oxygen is necessary for the healing process of tissue such as the skin and oxygen can also be used to kill certain microorganisms. This study aims to test how effective a hyper-oxidized oil-based gel known as is for patients affected by AC. This gel will deliver a higher concentration of oxygen to the areas affected by AC to promote healing and treat possible infection. The study will also collect microbiological swabs of the mouth and lips of patients with AC and healthy patients to compare the microorganisms present.
Who can participate?
Adults with a clinical diagnosis of angular cheilitis
What does the study involve?
Participants will be asked to use the medication Novox® Drop 2 times daily for 10 days. All patients will be carefully instructed on how to use the medication by applying the drop using a fingertip on the dried lesion after meals without eating, drinking, or speaking for at least half an hour afterward.
What are the possible benefits and risks of participating?
The direct benefit anticipated will be a reduction of reported pain.
The medication provided has been already used for other oral diseases, without showing any adverse effects. If the patients will manifest any reactions they will be recommended to stop the medication immediately and it is expected that in about one day adverse reactions will disappear.
Where is the study run from?
University of Turin (Italy)
When is the study starting and how long is it expected to run for?
From April 2018 to December 2021
Who is funding the study?
The University of Turin (Italy) supported the study. The MOSS spa (Italy) provided the medication used in the study.
Who is the main contact?
Prof Paolo Arduino
paologiacomo.arduino@unito.it
Contact information
Scientific
Via Nizza 230
Turin
10126
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | +390116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Study design | Prospective open-label non-randomized single-arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
| Scientific title | Assessment of topical applications of Novox Drop™, a hyper-oxidized oil, in the treatment of angular cheilitis: an uncontrolled pilot study |
| Study acronym | NDxACh |
| Study objectives | The use of Novox Drop™ twice daily for 10 days, could be useful in managing pain, and clinical appearance, in patients with angular cheilitis |
| Ethics approval(s) | Approved 01/02/2018, Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino (Corso Bramante, 88/90, 10126 Torino, Italy; +39 0116334732; urp@molinette.piemonte.it), ref: CIR-PO-pga2018/01aa |
| Health condition(s) or problem(s) studied | Angular cheilitis |
| Intervention | This is a prospective, open-label study, that involves giving a specific preparation (Novox® Drop is a class IIb medical device based on oxygen-enriched oil with Reactive Oxygen Species release) to a cohort of subjects with angular cheilitis. All patients were carefully instructed to apply the medication 2 times daily for 10 days using a finger rub application on the dried lesion after meals without eating, drinking, or speaking for at least 30 min afterward. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Novox Drop™ |
| Primary outcome measure | 1. Spontaneous pain intensity measured using the Visual Analogue Scale (VAS), consisting of a 10 cm-horizontal line marked with 0 (=no pain) to 10 (=most severe pain experienced) at baseline and 10 days 2. Microbiological flora measured using clinical evaluation and oral swabs at baseline and 10 days |
| Secondary outcome measures | 1. Clinical evaluation for the dimension of the lesion at baseline and 10 days 2. Unexpected effects of treatment recorded using a diary provided to patients between treatment start and 10 days |
| Overall study start date | 01/04/2018 |
| Completion date | 01/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Clinical diagnosis of angular cheilitis 3. No detectable oral mucosal lesions 4. Able to complete the present clinical trial |
| Key exclusion criteria | 1. Unable or unwilling to provide informed consent 2. Significant psychiatric or cognitive impairment 3. Pregnant or breast-feeding 4. History of allergy to ingredients present in Novox Drop™ |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 01/11/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Nizza 230
Turin
10100
Italy
Sponsor information
University/education
Via nizza 230
Turin
10126
Italy
| Phone | +390116331522 |
|---|---|
| paologiacomo.arduino@unito.it | |
| Website | https://www.dentalschool.unito.it/it |
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Turin in Italy, University of Turin, Italy, Università di Torino, 都灵大学, University of Turin, UNITO
- Location
- Italy
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The results of the primary and secondary endpoints along with any other reportable data will be published in peer-review journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/12/2021 | 14/01/2022 | Yes | No |
Editorial Notes
14/01/2022: Publication reference added.
16/02/2021: Trial’s existence confirmed by Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino.
