Post Marketing Observational Study PMOS to Evaluate the Safety and Efficacy of Creme Cleansing Baby Bar HBCS-011701 On Babies with Atopic Dermatitis Sensitive Skin In 0-36 Months Babies.
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Himalaya Wellness Company
- Enrollment
- 500
- Locations
- 20
- Primary Endpoint
- To evaluate the safety and efficacy of Test Product in study population.
Study Overview
Brief Summary
**STUDYOBJECTIVE:**To evaluate the safety and efficacy of Crème cleansingbaby bar on babies with atopic dermatitis – sensitive skin in 0-36 monthsbabies
**STUDY DESIGN:**An open label, postmarketing observational study.
StudyMethodology:
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Parents/LegallyAcceptable Representatives (LARs) of the baby will be provided with the parentalconsent document and explained about the study in detail.
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Babies who fulfil theselection criteria will be enrolled into the study after written parental consent.
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The subject’s parent/LAR will be provided with The Himalaya Crème cleansing baby bar, and they willbe instructed on the use the product by the study doctor/ coordinator.
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Assessments will beperformed on Day 1/baseline and at the end of the study visit (Day 14) as
per the schedule ofevents.
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If subjects score forLocal intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then the undesirableeffect page to be completed.
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All undesirableeffects to be followed up till the event is stabilized or 7days whichever isearlier
Studyduration: Thisstudy is planned for 2 Weeks/14 days. The subjects must use the test productfor all 14 days.
Numberof Subjects: 500 subjects will be enrolled.
**StudySite:**Thestudy will be conducted at 20 sites.
Directions to Use: Wet baby’s body withlukewarm water, create lather in your hand, and gently apply on your baby’sbody. Cleanse and rinse off with water.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 0.00 Day(s) to 36.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects in the age group of 0 to 36 months (inclusive of both genders).
- •2.Subjects with Atopic Dermatitis with at least one of the following symptoms: dryness, itchiness, redness, flaky skin.
- •3.Subjects in general good health as determined by investigator.
- •4.Subjects mother/legal representative willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject.
Exclusion Criteria
- •1.A known history or present allergic condition that may require medical attention.
- •2.Chronic illness which may influence the cutaneous assessment.
- •3.Subjects not willing to stop the use of other baby bath products or soap during the study product.
- •4.Subjects who have participated in a similar clinical investigation in the past four weeks.
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of Test Product in study population.
Time Frame: 14 days
Secondary Outcomes
- NA(NA)