213040

12 Week Parent and Child Study  - For children with a history of mild to moderate atopic dermatitis (Eczema)

Study Summary

Alba Science would like to invite you to participate in a 12 week parent and child study comparing the skin barrier effects of an infant food supplement and a placebo in children aged 1-5 years who have a hotory of mild to moderate atopic dermatitis (Eczema).

The infant food supplement (Vitamin) that we are testing contains the following:

Amino Acid L-Histidine

Zinc

Biotin

Vitamins B2, B3 and E

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If you child is accepted onto the study you will receive the food supplement and a 5ml syringe.

You will be required to give your child 5ml of product orally, once per day in the morning (before 12 Noon).

Screening/Baseline Visit

Upon attending the visit the subject’s parent/ legal guardian will provide written consent and your child will undergo a body examination by the screening doctor. 

The study examiner will then conduct their assessment using the EASI for under 8s scale and will identify the test site. Following this the subjects will undergo acclimatisation and during this time the parent/legal guardian will complete the questionnaire with the subject (if the subject is capable to understand the questions). Upon the completion of the minimum acclimatisation period, subjects will have instrumental readings taken from within the test site as per sections.

Once all instrumental measurements have been completed the subject will be randomised and the parent/ legal guardian will be dispensed the product as per the randomisation schedule. The product will be weighed before being dispensed in order to monitor compliance with use instructions. The parent/legal guardian will be instructed in the use of the product and a supervised first use of the product will be conducted. The parent/ legal guardian will be given a diary card to record the time each day in which the product is administered to their child. The date and time of the first use will be recorded in the diary card (note: some subject’s first dose will be in the afternoon due to appointment schedule).They will also be provided with the questionnaire to complete on product use. An appointment will then be made for the subject and parent/ legal guardian to attend the following visit.

Visit 3 (Week 2), Visit 4 (Week 4), Visit 5 (Week 8) and Visit 6 (Week 12) – Each visit can be +/- 2 days from Visit 2 Baseline (Week 0)

Upon attending the visit the subject’s parent/ legal guardian will be asked if there have been any changes to their child’s health and/or medication being taken since their last visit and any changes will be recorded on the appropriate CRF. Subject compliance to the study restrictions will be assessed by the questioning of the parent/ legal guardian and any non-compliance will be recorded as a deviation.

The study examiner will then conduct their assessment and will re-identify the test site. Following this the subjects will undergo acclimatisation and during this time the parent/legal guardian will complete the questionnaire with the subject (if the subject is capable to understand the questions). Upon the completion of the minimum acclimatisation period, subjects will have instrumental readings taken from within the test site.

Compliance regarding product use will be checked through the review of the diary card along with the weighing of the product and any reinstruction in product use required will be given. Additional product will be dispensed at Visit 4 (Week 4) and Visit 5 (Week 8). The parent/ legal guardian will also be provided with the questionnaires to be completed at home on product use Days 22 (Week 3), 36 (Week 5), 43 (Week 6), 50 (Week 7), 64 (Week 9), 71 (Week 10) and 78 (Week 11)(+/- 2 days). An appointment will then be made for the subject and parent/ legal guardian to attend the following visit.

At Visit 6 (Week 12), in addition the procedures above the product and diary card will be collected and the parent/ legal guardian will be given the subjects payment for taking part in the study.

Attendance – 5 Visits

To be able to take part in this study you must attend all 6 visits.

Visit

Date

Approx. Length of Study Visit

Screening/Baseline Visit

Wednesday 18 October 2017

Approx. 90 minutes

Week 2

Wednesday 01 November 2017

Approx. 60 Minutes

Week 4

Wednesday 15 November 2017

Approx. 60 Minutes

Week 8

Wednesday 13 December 2017

Approx. 60 Minutes

Week 12

Wednesday 10 January 2017

Approx. 60 Minutes

Inclusion Criteria

Subjects must be:

Male or Female.

Age 1 – 5 inclusive at screening.

Subjects parent/legal guardian is willing and capable to follow the study requirements and can attend all visits with their child.

Subjects with mild to moderate atopic dermatitis as confirmed by the screening doctor in consultation with the parent/ guardian.

Subjects who are in good mental health.

Subjects with skin tone pale enough to allow for the examiner assessment to be conducted.

Exclusion Criteria

You will not be eligible to take part in this study if any of the following applies:

Subjects with skin diseases, except mild to moderate atopic dermatitis on any part of the body that may impact the subject safety or well-being or affect the response of the skin or the interpretation of the test results in the opinion of the screening doctor.

Subjects with severe atopic dermatitis in the opinion of the screening doctor.

Subjects with significant history of any liver, kidney, heart, lung, digestive, blood, nerve, brain or psychiatric disorder/disease that may impact the subject safety or wellbeing and affect the response of the skin or the interpretation of the test results in the opinion of the screening doctor.

Subjects who received any of the following topical or systemic treatments:

 

1 - Cough suppressants and/or oral/inhaled steroids during the previous 2 weeks.

2 - Retinoids and/or immunosuppressants during the previous 6 months.

3 - Regular use of anti-inflammatories and/or anti-histamines.

4 – Regular use of topical steroids (intermitted rescue therapy to treat the condition is permitted).

Subjects who have been exposed to intense sunlight or artificial sources of URV within 30 days.

Subjects with a known allergy or sensitivity to any ingredients of the study products.

Subjects who are in care.

Study Restrictions

The Subjects Parent/legal guardian will be instructed that the following restrictions apply to their child/baby throughout the study:

Not to change any skin care, hygiene or cleansing products/regimes for the duration of the study. (intermittent use of rescue therapy topical steroid creams are permitted).

Not to start taking any other dietary supplements for the duration of the study.

No exposure to the sun that would result in tanning or burning of the skin.

No long soaks in the bath for the duration of the study.

Avoid rubbing the arms when drying the skin for the duration of the study.

Avoid the use of medicines such as anti-inflammatories, anti-histamines, cough suppressants, topical/inhaled steroids, retinoids, and/or immunosuppressants.  (If it is necessary for any of these medications to be taken,  please inform a member of the study team at the next visit).

In addition, the following restrictions will apply before visit 2 – 6.

Not to use any skin products on the body within 4 hours prior to each test visit.

Not to apply water to the arms within 2 hours prior to each visit.

Not to shower/ Bathe within 10 hours prior to each test visit.

No swimming within 24 hours prior to each test visit.

Not to consume any spicy foods, hot drinks, cranberry juice or food or drink containing caffeine within 1 hour prior to each visit.

Expenses

You will be paid a £190 cheque in your name on completion of this study.

How to Apply

To take part in this study please email recruitment@albavolunteers.com or call 08007561046.