Safety and Efficacy Study of Kids Lotio
- Registration Number
- CTRI/2020/06/025686
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method