Clinical trial NCT06015217: A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash
Official title: An Open-label Study to Assess Efficacy and Safety of a Healing Ointment When Used on Infants With Mild-to-moderate Diaper Rash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diaper Rash
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study only has a single group, and all subjects receive the same treatment.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the efficacy and safety of a Healing Ointment in infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer is:

• does a Healing Ointment improve skin texture and smoothness in infants with mild to moderate diaper dermatitis? Participants will use a Healing Ointment on the diaper area with every diaper change, have the Investigator perform efficacy and tolerability assessments, and complete questionnaires regarding subject satisfaction.


Eligibility criteria: 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

Primary outcomes:
measure: Product Efficacy
timeFrame: Week 1, Week 3
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: Day 1, Week 1, Week 3
measure: Product Tolerability
timeFrame: Week 1, Week 3
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: Young Skin MD
state: Florida
Study officials:
affiliation: Young Skin
name: Latanya Benjamin
role: PRINCIPAL_INVESTIGATOR
References: