None listed
Conditions
Interventions
Intervention1: 1 Arm 1: HKBL-111616 (D)
2 Arm 2: HKBL-111616 (Su)
3 Arm 3: HKBL-111616 (S): The products will be applied on all over kidâ??s body after bath or as when required twice daily for 15 days
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: For Arm 1, Arm 2 and Arm 3 1. Subjects in the age group of 4 to 12 years (inclusive of both genders). 2. Subjects parents/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up and verbal/oral assent from children between 7 to 12 years of age in the presence of their parent/legal guardian/caregiver. 3. Subjects parents/legal representative, preferably mother willing to abide by and comply with the study protocol. 4. Subjects generally having dry skin. 5. Subjects should not participate in any other clinical study during participation in the current study. For Arm 3 1. Kids with skin rashes, itching, dryness, erythema, scaliness, eczema, atopic dermatitis for HKBL-111616 (S) variant.
Exclusion criteria
Exclusion criteria: 1. Subjects with Chronic illness which may influence the cutaneous state. 2. Subjectâ??s mother/ legal representative not willing to stop the use of other kids lotion during the study period. 3. Subjects not on any systemic medication. 4. Subjects with birth defects and anomalies. 5. Subjects with medical history (past and present) of significant dermatological diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes. 6. Any subject, in the investigators opinion not considered suitable for enrollment. 7. Subject participating in a similar clinical study, currently or during the previous 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Arm 1, Arm 2 and Arm 3: Evaluate the safety and efficacy of Kids Lotion in children of 4-12 years of age. Evaluate the skin mildness, gentleness and irritability of kidâ??s skin by pediatrician. Evaluate the product safety by skin tolerance evaluation by Dermatologist Trained Evaluator. For Arm 3: Evaluate the Dermatological tolerability in kids with skin rashes, itching, dryness, erythema scaliness, eczema, atopic dermatitis.Timepoint: Visit 1 baseline at Day 1, Visit 2 Day 7, Visit 3 Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed