Use of Novox oil in the management of angular cheilitis

Assessment of topical applications of Novox Drop™, a hyper-oxidized oil, in the treatment of angular cheilitis: an uncontrolled pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26092754

Enrollment

Registered

2021-02-24

Start date

2018-08-01

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angular cheilitis Digestive System Cheilitis: angular

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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™

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026