New ointment soothes Baby's bottom: study shows promise for diaper rash
NCT ID NCT06015217
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a healing ointment on 26 infants aged 2-24 months with mild-to-moderate diaper rash. Parents applied the ointment at every diaper change for a set period. Doctors checked skin texture and smoothness, and parents reported satisfaction. The goal was to see if the ointment safely improves diaper rash.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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26 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Dec 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 24 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The subjects must meet all the following criteria to be eligible for the study: 1. Infant subjects aged 2 months to 24 months 2. Females and males 3. All Fitzpatrick skin types I-VI 4. All races and ethnicities 5. Subject diagnosed with mild-to-moderate diaper rash 6. Subject with healthy immune systems 7. Willing to be photographed at each visit (optional) 8. Willing to abstain from use of any other topical diaper rash treatments (ointments, moisturizers, emollients, creams, and wipes) other than the assigned test product and skincare products that have been routinely used on the diaper area during the duration of the study 9. Willing to continue using regular brands of face/body cleanser and not to begin use of any new skincare products other than the test product for the duration of the study 10. Parent/legal guardian/legal guardians must be at least 18 years old and are willing and able to present proof of legal guardianship 11. Parent/legal guardian/legal guardian with ability to read, understand and give consent for participation in the study 12. Parent/legal guardians/legal guardians willing to sign a photography release form 13. Parent/legal guardian/guardian must agree to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments Exclusion Criteria: * The presence of any of the following exclusion criteria excluded a subject from enrollment in the study: 1. Subject diagnosed with severe diaper rash 2. History of allergy or hypersensitivity to any ingredient of the test product 3. Presence of any disease or lesions near or on the area to be treated, e.g., 1. Inflammation, active, or chronic infection in or near the treatment area 2. Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis 3. Scars or deformities 4. History of coexisting bacterial infections or medical conditions with uncontrolled gastrointestinal diseases and/or bowel movements 5. History of severe elastosis and/or excessive sun exposure that, in the opinion of the Investigator, could have affected the outcome of the study 6. Planning on having surgeries and/or invasive medical procedures during the course of the study 7. Treatment with chemotherapy, immunosuppressive agents, inhaled corticosteroids, immunomodulatory therapy (e.g., monoclonal antibodies or antiviral treatment for human immunodeficiency virus or hepatitis C) 8. Current use of topical corticosteroids, topical prescription, or oral antibiotics in the treatment area, or use within last 2 weeks 9. Current use of over-the counter topical medications for diaper rash 10. History of cancer or previous radiation near or on the treatment area 11. Human immunodeficiency virus positive or active hepatitis 12. Presence of dermal markings on or near the treatment area that, in the opinion of the Investigator, will interfere with the clinical assessments 13. Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g., a chronic or relapsing, disease that may interfere with the outcome of the study) 14. Other condition preventing the subject from entering the study in the Investigator's opinion, (e.g., subjects failing baseline assessments, subjects not likely to avoid other cosmetic treatments in the treatment area, subjects anticipated to be unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result). 15. Study site personnel, close relatives of the study site personnel (e.g., parent/legal guardians, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company. 16. Participation in any interventional clinical study within 30 days of screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Young Skin MD
Coral Springs, Florida, 33067, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.