None listed
Conditions
Interventions
Intervention1: Baby Diaper Rash Cream: External Use Spread the Diaper Rash Cream generously on the babyâ??s buttocks and thighs area
Use daily for 14 days each time diaper change happens
Control Inte
Sponsors
Azafran Innovacion ltd
Eligibility
Inclusion criteria
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. 11 Babies mother or legal representative preferably mother willing to abide by and comply with the study protocol. 12 Babies should not participate in any other clinical study during participation in the current study.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate rash skin overall severity scoring scale and Scoring for erythema redness dryness itching & rashes 2. Safety on skin mildness, gentleness and non-irritability of babiesâ?? skin by using Pediatrician Assessment Scoring 3. Skin hydration using Corneometer® CM 825 or MoistureMeterSC 4. To evaluated on skin barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or VapoMeterTimepoint: Day 01 Baseline and Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective Assessment Questionnaire from babiesâ?? mother or legal caretakerTimepoint: Day 15 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed