Effect of test product on mild to moderate diaper rashes
- Registration Number
- CTRI/2021/02/031265
- Lead Sponsor
- Zydus Wellness Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
1. Baby in the age group of 0 including newborn babies Day 1 to 36 months inclusive of both genders at the time of consent.
2. Baby generally in good health as determined from recent medical history.
3. Baby who wears diapers at least 12 hours per day.
4. Babies with the presence of Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator
5. Baby mother or legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
6. Baby mother or legal representative, willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments, lotions, creams, or powders during the trial.
7. Baby mother or legal representative willing to refrain from changing any other products whose use may have an effect on their childs skin condition during the trial example laundry detergents, fabric softeners, and products used to bath the child.
8. Baby mother or legal representative, preferably mother willing to abide by and comply with the study protocol.
9. Babies should not participate in any other clinical study during participation in the current study.
1. Baby mother or legal caretaker not willing to stop the use of other baby body milk or lotion or cream or any other baby face or body moisturizing product during the study period.
2. Chronic illness which may influence the cutaneous state.
3. Babies currently being toilet trained.
4. Baby participating in a similar clinical study, currently or during the previous 30 days.
5. Any Baby, in the Investigators opinion not considered suitable for enrollment.
6. A known history or present condition of allergic response to any other concern that may require medical attention.
7. Babies with medical history past or present of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, vitiligo or other conditions known to alter skin appearance or physiologic response example porphyria, chronic urticaria, or sunburn, rashes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method