A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash

NCT ID: NCT06015217

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2023-12-13

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.

Conditions

Diaper Rash

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.

Group Type: EXPERIMENTAL

"Cetaphil Healing Ointment"

Intervention Type: DRUG

Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change

Interventions

"Cetaphil Healing Ointment"

Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Latanya Benjamin

Role: PRINCIPAL_INVESTIGATOR

Young Skin

Locations

Young Skin MD

Coral Springs, Florida, United States

Countries

United States

Other Identifiers

GLI.04.US.SL.027

Identifier Type: -

Identifier Source: org_study_id