CTRI/2020/08/027020
Completed
未知
Safety In-Use Study to Assess the Cutaneous Tolerance of Tear Free Baby body wash and Shampoo in Healthy Babies of 0 to 36 Months of Age.
Azafran Innovacion ltd0 sites38 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Azafran Innovacion ltd
- Enrollment
- 38
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Babies in the age group of 0 (including new born full term babies Day 1\) to 36 months (inclusive of both genders) at the time of consent
- •2 Babies general in good health as determined from a recent medical history
- •3 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up
- •4 Babies mother or legal representative preferably mother willing to abide by and comply with the study protocol
- •5 Babies should not participate in any other clinical study during participation in the current study
Exclusion Criteria
- •1 Subjectââ?¬•s 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 Subject on any systemic medication
- •4 Subject with birth defects and anomalies
- •5 Subject participating in a similar clinical study currently or during the previous 30 days
- •6 Any subject in the Investigators opinion not considered suitable for enrollment
- •7 A known history or present condition of allergic response to any other concern that may require medical attention
- •8 Babies with medical history (past present) of significant dermatological diseases or conditions such as atopy psoriasis vitiligo or other conditions known to alter skin appearance or physiologic response (eg.porphyria) chronic urticaria or sunburn rashes
Outcomes
Primary Outcomes
Not specified
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