None listed
Conditions
Interventions
Intervention1: Body lotion HBBM-091723: Apply the product in morning after bath and before sleep at night for twice a day for 2 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1) Babies in the age group of 0 (including new born 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/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up. 4) Babies mother/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. Additional Criteria for babies with atopic dermatitis. 6) Babies generally with atopic dermatitis as per dermatologist examination.
Exclusion criteria
Exclusion criteria: 1) Babiesâ?? mother/ legal representative not willing to stop the use of other body lotion for their baby during the study period. 2) Babies on any systemic medication. 3) Babies with birth defects and anomalies. 4) Babies participating in a similar clinical study, currently or during the previous 90 days. 5) Any Babies in the investigators opinion not considered suitable for enrollment. 6) Babies with medical history (past and 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Improvement in the skin hydration by Corneometer before and after application. 2. Reduction in the rate of water loss from skin layer by TEWAmeter before and after application. 3. Evaluate the skin mildness, gentleness and irritability of babies skin by pediatrician before and after application. 4. Tolerability in babies with skin rashes, itching, dryness, erythema scaliness, eczema, atopic dermatitis.Timepoint: 1. Visit 01 (Day 01), Visit 02 (Day 07) and Visit 03 (Day 15) 2. Visit 01 (Day 01), Visit 02 (Day 07) and Visit 03 (Day 15) 3. Visit 01 (Day 01), Visit 02 (Day 07) and Visit 03 (Day 15) 4. Visit 02 (Day 07) and Visit 03 (Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective assessment questionnaire by the babies mother/ legal representative 2. Assess safety of Babies skin by local intolerance evaluation of test product as per Appendix IV and Incidence of adverse event: Either self-reported by mother/legal representative of babies or assessed by Pediatrician. Timepoint: 1. Visit 02 (Day 07) and Visit 03 (Day 15) after application. 2. Visit 02 (Day 07) and Visit 03 (Day 15) after application. | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed