Active-controlled, randomized, open-label, comparative study of the efficacy and safety of dioctyl sodium sulfosuccinate otic solution 5% "CEO"

Active-control,randomized, open-label controlled trial comparing the efficacy and safety of dioctyl sodium sulfosuccinate otic solution 5% "CEO" for navel dirt removal before abdominal surgery

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200058

Enrollment

Registered

2020-06-29

Start date

2020-07-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

healthy

Interventions

Groups A to C: Study drug (dioctyl sodium sulfosuccinate otic solution 5% "CEO") Once a day, several drops are adapted and left for 1 minute (Group A), 5 minutes (Group B), 10 minutes (Group C), and t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Those who have not cleaned the navel dirt for more than 6 months (except for bathing) 2)Those who can confirm the navel dirt by visual inspection 3)Age 20 or older at the time of obtaining informed consent 4)Male or female 5)A person who has given written informed consent to participate in this research

Exclusion criteria

Exclusion criteria: 1)Patient who has had a history of incision of the navel by surgery 2)Inflammation, pain, itching, redness, eczema, etc. in and around the navel 3)Those who have decorated the navel with piercings, tattoos, etc. 4)Those who have almost no dents in the navel due to umbilical hernia 5)Patients with skin disorders, mental disorders (particularly those who are prone to self-harm), liver disorders, kidney disorders, cardiovascular disorders, blood disorders, endocrine disorders, etc. or those who have a history of these 6)Those who are allergic to dioctyl sodium sulfosuccinate, glycerin and propylene glycol , oliv oil 7)Patients with a history of severe allergy, asthma or drug sensitivity 8)Alcohol dependence or drug dependence (including suspect), or those who have a history of these 9)Positive drug screening test for abuse 10)Those who are positive for HBs antigen, HCV antibody, HIV antigen / antibody, or syphilis serum reaction 11)Those who are using concomitant therapy (administration of antibacterial agents to and around the umbilicus, antibacterial agents and umbilical cleaning (excluding bathing)) and, therefore, those who plan to perform concomitant therapy by the end of the test 12)Patients who have been treated with other clinical trial drugs within 16 weeks before administration of the study drug 13)Others who are judged to be ineligible by the investigator

Design outcomes

Primary

Measure	Time frame
The removal effect of the navel dirt(Reduction rate of navel dirt)	—

Secondary

Measure	Time frame
1)Anti- bacterial effect in umbilical position(Comparison of CFU (Colony Forming Unit),bacteria count reduction) 2)Evaluation of safety	—

Contacts

Public ContactMiki Sasaki

Shinanozaka Clinic

m-sasaki@shinanokai.com+81-3-5366-3006

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026