CTRI/2020/08/027380
Completed
未知
Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Soap in Healthy Babies of 0 to 36 Months of Age
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Azafran Innovacion Limited
- 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 of Day 1\) to 36 months (inclusive of both genders) at the time of consent.
- •2\)APGAR score \>7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0\-7 days.
- •3\)Babies general in good health as determined from a recent medical history
- •4\)Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
- •5\)Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
- •6\)Babies should not participate in any other clinical study during participation in the current study.
Exclusion Criteria
- •1\)Babiesââ?¬• mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / massage oil or any other baby face/body moisturizing product during the study period.
- •2\)Chronic illness which may influence the cutaneous state as per Investigator.
- •3\)Babies on any systemic medication.
- •4\)Babies 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 \| present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Safety in use studyCTRI/2020/09/027574Azafran Innovacion ltd38
Completed
Not Applicable
Safety study of baby creamCTRI/2020/08/026966Azafran Innovacion Limited38
Completed
Not Applicable
Safety in Use StudyCTRI/2020/09/027540Azafran Innovacion ltd38
Completed
Not Applicable
Safety in Use Study.CTRI/2020/08/027020Azafran Innovacion ltd38
Completed
Not Applicable
Safety assessment of product on skiCTRI/2019/07/019999The Procter Gamble Company120