Safety in use study

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1 Babies in the age group of 0 to 36 months inclusive of both genders at the time of consent 2 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
3 APGAR score greater than 7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0 to 7 days.
4 Babies general in good health as determined from a recent medical history.
5 Parent or guardian willing to use only the test product in the diaper area during the trial.
6 Parent or guardian 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 Parent or guardian is willing to refrain from changing any other products whose use may have an effect on their child skin condition during the trial ie laundry detergents fabric softeners and products used to bathe the child.
8 Wear diapers 24 hours per day.
9 Present to the test facility for enrollment at baseline with diaper rash receiving an Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator.
10 Babies with mild to moderate rashes on buttocks and or thigh area assessed by Dermatologist or Dermatologist Validated Scorer using scoring scale will be included in the study.
12 Babies should not participate in any other clinical study during participation in the current study.

Exclusion Criteria

1.Babiesâ€™ mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / diaper rash cream or any other baby body moisturizing product during the study period.
2.Chronic illness which may influence the cutaneous state.
3.Babies on any systemic medication.
4.Babies currently being toilet trained.
5.Babies participating in a similar clinical study, currently or during the previous 30 days.
6.Any baby, 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, eczema, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate rash skin overall severity scoring scale and Scoring for erythema redness dryness itching & rashes	Day 01 Baseline and Day 15
2. Safety on skin mildness, gentleness and non-irritability of babiesâ€™ skin by using Pediatrician Assessment Scoring	Day 01 Baseline and Day 15
3. Skin hydration using CorneometerÂ® CM 825 or MoistureMeterSC	Day 01 Baseline and Day 15
4. To evaluated on skin barrier function by transepidermal water loss (TEWL) using TEWAmeterÂ® TM 300 or VapoMeter	Day 01 Baseline and Day 15

Secondary Outcome Measures

Name	Time	Method
Subjective Assessment Questionnaire from babiesâ€™ mother or legal caretaker	Day 15

Trial Locations

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Nayan Patel
Principal investigator
9909013286
nkpatel@cliantha.com