None listed
Conditions
Interventions
Intervention1: Head-to-Toe Baby Wash: Apply to the scalp, face and whole-body during bath for 7 days.
Intervention2: Baby Wet Wipes: Apply to the face whole body and diaper area during diaper changes
Sponsors
Mother Sparsh Baby Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with all skin types (dry, normal, oily, combination, sensitive, and eczema-prone), as assessed by a dermatologist, and in good general health based on medical history and physical examination. 2. Subject wearing diaper at least for 12 hours per day. 3. Parent or legal representative (preferably the mother) provides written informed consent and agrees to attend follow-ups and comply with the study protocol. 4. Subject must not participate in any other clinical study during this study.
Exclusion criteria
Exclusion criteria: 1.Subject above 6 years of age. 2. Subject with known allergy or chronic illness that may affect cutaneous assessment or require medical attention. 3. Subjects parent/legal representative not willing to stop use of other lotions during the study period, or the subject is on any systemic medication. 4. Subject with birth defects, chromosomal/metabolic anomalies, or significant dermatological diseases/conditions (e.g., atopy, psoriasis, vitiligo, porphyria, chronic urticaria, sunburn, rashes) that may alter skin appearance or physiological response. 5. Subject judged by the investigator to be inappropriate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in overall scalp, hair, and skin condition, ocular safety assessed by parents, investigators, and ophthalmologist.Timepoint: Baseline and End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the scores of safety and tolerability scales of test products by the investigator and also basis parent s daily observation record.Timepoint: Baseline and End of Treatment | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed