None listed
Conditions
Interventions
None listed
Sponsors
Mother Sparsh Baby Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in good health as determined from a recent medical history and physical examination. 2. Subjects whose parent/legal representative, preferably the mother, is willing to provide voluntary written parental informed consent and agrees to abide by, comply with the study protocol, and attend regular follow-up visits. 3. Subjects should not participate in any other clinical study during participation in the current study.
Exclusion criteria
Exclusion criteria: 1. Subjects above 36 months of age. 2. Subjects with known history or current allergic conditions requiring medical attention, or chronic illnesses that may influence the cutaneous assessment. 3. Subject s mother/legal representative not willing to stop the use of other lotions/oils during the study period. 4. Subjects on any systemic medication or with birth defects and chromosomal or metabolic anomalies. 5. Subjects participating in a similar clinical study currently or within the previous 30 days. 6. Subjects with medical history (past or present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiological response (porphyria), chronic urticaria, or sunburn, rashes. 7. Subjects judged by the investigator to be inappropriate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the scores for overall scalp and hair condition, overall skin condition following the use of the test products, and mean change in the scores of the safety and tolerability scales of the test product.Timepoint: Baseline, Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the scores for assessment of babys quality of life on using the baby oils by investigators assessment.Timepoint: Baseline, Day 8;Mean change in babys sleep onset time, sleep duration and number of awakenings / sleep interruptions on using the baby oils with parent recorded subject diary.Timepoint: Baseline, Day 8 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed