A Tolerability Assessment Study of Three Wash Products in Infants

Study Overview
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Brief Summary
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This will be a single centre, evaluator blind, randomized, parallel group, stratified, two week study in healthy participants. The clinical study is designed to provide reassurance that the formulations developed for children and babies with mild to moderately dry skin and for children whose skin is prone to atopic dermatitis (eczema) are well tolerated in the target population, babies and young children with dry skin.

Official Title
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A Clinical Study in Infants to Assess the Tolerability of Three Wash Products

Conditions
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Skin Care

Intervention / Treatment
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* Other: Test shampoo
* Other: Test bath foam
* Other: Test head to toe wash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants up to 18 months of age at the screening/baseline visit with good general health and no major physical disabilities Parent/legal guardian reported dry skin Voluntary written informed consent form by parent/legal guardian as an evidence to understanding of the study and willingness to participate Exclusion Criteria: Allergy/intolerance or hypersensitivity to the study material or any of their stated ingredients Participant with skin condition that warrants medical intervention, current episode of eczema/atopic dermatitis or has had an episode in the 3 months prior to screening, not regular use of moisturizers (variable application frequency) Use of oral corticosteroids/immunosuppressive medication within 4 weeks or topical corticosteroids/topical anti-itch products within 2 weeks of baseline Child in Care; participants' previous participation in this study/another clinical study/receipt of investigational drug within 30 days of the screening visit Parent/legal guardian aged 18 years or under, employee of the sponsor or the study site or members of their immediate family Participant living in the same household of an already enrolled participant

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test shampoo<br>Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | Other: Test shampoo<br>* Participants used Oilatum Soothe & Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.<br>|
| Experimental: Test bath foam<br>Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | Other: Test bath foam<br>* Participants used Oilatum Soothe & Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.<br>|
| Experimental: Test head to toe Wash<br>Participants' will be instructed to use the test product as per the label instructions for a minimum of twice per week for 2 weeks. | Other: Test head to toe wash<br>* Participants used Oilatum Soothe & Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability Assessment of Test Products | The tolerability of the test products under normal conditions of use was assessed by the paediatrician using a 5 point scale: where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor. | At Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin) | The changes in participants' skin condition was assessed using the ODS score: where 0= Absent; 1= Faint scaling, faint roughness and dull appearance; 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks. | At baseline and day 14 |