Efficacy and Safety of Remo-Wax® Oil (RWO) in Subjects With Isolated Itching of the External Ear Canal (Remo_Itch)
Itching
About this trial
This is an interventional treatment trial for Itching
Eligibility Criteria
Inclusion Criteria: Written Informed Consent obtained. ≥12 years old male or female subjects who, in the opinion of the Investigator, are able to comply with the study procedures and evaluations Subjects with complaints of recurrent or continuous unilateral or bilateral itchy ear canals A score of at least 5 in subjective pruritus evaluation using a score of itching between 0 (none) and 10 (extreme) in the ear canal at its worst in the previous four days No ear-related abnormal findings in an ENT examination by an otolaryngologist, with the exception that mild to moderate irritation in the ear canal is allowed For participants who are minors: A representative/caregiver (per local requirements) available, who provides the Informed Consent on behalf of the minor subject and who is accompanying the subject at the study visits, as relevant, and supports the subject with home administrations and filling in the study diary, as relevant Exclusion Criteria: Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions History of tympanic membrane perforation or tympanostomy tubes in the previous 6 months External ear or ear canal infection/inflammation in the previous 30 days Otitis media/myringitis in the previous 30 days Past ear surgery Otorrhea in the previous 30 days Temporal bone neoplasm Presence of known or suspected mastoiditis Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data (e.g. impacted cerumen, ear eczema or seborrhoea, ear canal stenosis, exostoses). Subjects with a history of long-term topical or systemic steroid and/or antibiotic use (according to Investigator's judgement), and those who had used topical or systemic steroids and/or antibiotics in the previous 30 days Subjects with systemic disease such as diabetes mellitus, renal or hepatic disorders, or dermatological disease such as psoriasis or atopic dermatitis Participation in a clinical drug study or another clinical investigation within 60 days prior to the start of the present study Subjects who are not able to perform the administrations by themselves
Sites / Locations
- Vilnius University Hospital
Arms of the Study
Arm 1
Experimental
Treatment
Treatment with RemoWax Oil