213505

Facial Moisturisation & Blood Sampling Study

Study Summary

Introduction

You are invited to participate in a clinical research study where you will be required to use a facial product, once daily for 14 days.  Blood samples will be collected from you by a trained phlebotomist on 9 occasions during the study, (prior to the first product application, and then following the first application at 2, 5, 8, 12, 24 and 48 hours, and at Day 7 and Day 14).  Analysis will be performed on your blood donations, these will  tell us how much time it takes for the ingredients to be absorbed into your body from the study product and how long it stays there.

 

Study Overview

There will be approximately 15 volunteers enrolled onto the study, who will be required to visit the test centre on 5 occasions over a 14 day period.  You should note that the 1st visit will last for up to 14 hours and volunteers will be required to remain at the test centre throughout this period. Subsequent visits will last for approx. 60 min.

You will first go through the screening procedures; the purpose is to see if you qualify to participate in the study. Please note that your participation is subject to you fulfilling certain criteria:

For this study you must be female, be in good general health and be aged 45-65. You must be willing to take a urine pregnancy test (if pre-menopausal) at the beginning and end of the study, have skin that is free from cuts, large scars, and abrasions on your face and have no active skin conditions or other skin disorders (e.g. eczema, dermatitis or psoriasis). 

You should not have had eczema or psoriasis on your hands or face during your adult life or have used topical, systemic, or inhaled steroids within the last 6 months.  Individuals that are sensitive to adhesives or latex gloves or who are overly sensitive to blood sampling procedures will also be excluded.

You should not have provided a blood donation for any other organisation or have participated in any other study involving blood donations within 12 weeks prior to the start of this study.

If you are found to be ineligible to take part in the study, you will be paid £5 to compensate for your time and inconvenience.

 

What you will be asked to do:

Day 1 (Visit 1):  Screening, enrolment procedures, blood sampling and product application (approx.14 hrs duration)

You should not apply any facial products or make-up on the day of your test centre visit.

If you do match the inclusion criteria, results of your pregnancy test is negative and you are accepted onto the study, a trained phlebotomist (somebody who specialises in drawing blood), will collect 9ml of blood from you in the following manner:

·         A tourniquet will be applied to your arm, and the area swabbed with a suitable cleansing wipe.

·         The needle will be inserted into the vein, and a maximum sample of 9ml (about 2 teaspoons) will be taken.

·         When the sample has been taken, the tourniquet will be removed and the needle withdrawn from your arm. A piece of gauze will be applied until the bleeding stops.

·         When the bleeding has stopped, another piece of gauze or a plaster will be applied to the site.

No more than 30 min later, you will be asked to apply 0.8g 4 pumps (2 pumps per side of face) of study product to your face, and asked to gently rub it into your skin, until fully absorbed.  You must wash your hands after applying.

You will have to stay within the test centre for the remainder of the day and are not allowed to leave the facility for breaks.  Further blood samples will be taken throughout the day at 2, 5, 8 and 12 hours after 1st application of the product. 

Please note: 

You would need to bring your own food and refreshments (there are no food restrictions for this study), these are not provided by the test centre.  As the duration of your visit could be long (up to 14 hours), please bring books, magazines, a lap top etc. to entertain yourself.

Day 2 (Visit 2) Blood sampling and Product Application (approx. 60 min)

You should not apply any facial products or make-up on the day of your test centre visit. 

At all visits to ensure your compliance with the protocol requirements, a health and medication check will be performed.

You will be asked to provide a blood sample (9ml), have a facial assessment performed and asked to apply the product to your face.  Again, the product will be gently rubbed into your skin until absorbed and your hands washed before leaving the test centre.

Day 3 (Visit 3) Blood sampling and Product Application (approx. 60 min)

You should not apply any facial products or make-up on the day of your test centre visit.  Compliance with the protocol requirements and a health and medication check will be performed.  You will be asked to provide a blood sample (9ml), have a facial assessment performed and asked to apply the product to your face.  Again, the product will be gently rubbed into your skin until absorbed and your hands washed.

You will be provided with the study product and a diary on which to record the date and time of each application and instructions to enable application at home for the next three days.  You are requested to apply the product at the same time daily as observed at the test centre on your previous visits.

Please follow the instructions carefully and record all the information as instructed. Failure to do so might result in your early withdrawal from the study.

Day 7 (Visit 4) Blood sampling and Product Application (approx. 60 min)

Please ensure that you bring your product and diary sheet to this visit.  You should not apply the test product, any other facial products or make-up on the day of your test centre visit.

Compliance with the protocol requirements and a health and medication check will be performed.  You will be asked to provide a blood sample (9ml), have a facial assessment performed and asked to apply the product to your face.  Again, the product will be gently rubbed into your skin until absorbed and your hands washed.

You will be provided with the study product and a diary on which to record the date and time of each application and instructions to enable application at home for the next seven days.  You are requested to apply the product at the same time daily as observed at the test centre on your previous visits.

Day 14 (Visit 5) Blood sampling and Product Application (approx. 60 min)

Please ensure that you bring your product and diary sheet to this visit.  You should not apply the test product, any other facial products or make-up on the day of your test centre visit. You will also provide another urine sample for a pregnancy test to be performed.

Compliance with the protocol requirements and a health and medication check will be performed.  You will be asked to return your test product and diary sheet and to provide a blood sample (9ml) and have a facial assessment performed.  Once this has been completed you will receive your expenses.

Attendance – 5 Visits

 

 

Visit

Date

Length Of Appointment

Appointment Times

Day 1

Wednesday 07 November 2018

Approx. 14 Hours

Appointments will run between 7:15am – 8:30am

Day 2

Thursday 08 November 2018

Approx. 1 Hour

Appointments will run between 7:45am – 9am

Day 3

Friday 09 November 2018

Approx. 1 Hour

Appointments will run between 7:45am – 9am

Day 7

Wednesday 14 November 2018

Approx. 1 Hour

Appointments will run between 7:45am – 9am

Day 14

Wednesday 21 November 2018

Approx. 1 Hour

Appointments will run between 7:45am – 9am

You must be able to attend all of the above visits to take part in this study.

Inclusion Criteria

Subjects must be:

 

Females.

Aged 45 to 65 years inclusive.

Facial skin that is free from cuts, large scars, and abrasions at the test site as determined by the clinical evaluator.

If pre-menopausal or of child bearing potential, be willing to take a urine pregnancy test at their baseline and the final visit.

Currently prescribed and taking hormonal contraceptives, If taking hormonal contraceptive, subjects will continue their normal regimen throughout the study

Be available for all study visits.

Be willing to follow all instructions regarding study product usage

Be willing to follow restrictions on the use of any other skin care product on the testing sites (entire face) for the entire duration of the study.  Subjects may wear daily make-up but during all visits no make-up is allowed.

Be willing to refrain from consuming grapefruit/grapefruit juice for the duration of the study.

Be willing and able to read and sign an Informed Consent Form and carry out all study procedures as described in the subject information sheet.

Exclusion Criteria

The following Exclusion Criteria will be used during subject recruitment:

Currently pregnant, pregnancy within the previous 12 months, intend to get pregnant during the study or breast feeding.

Individuals with eczema or psoriasis on the hands or face during their adult life.

Individuals that have used topical, systemic, or inhaled steroids within the last 6 months

Known allergies or sensitivities to steroids.

Individuals that are sensitive to adhesives or latex gloves.

Individuals with an immunological disorder or blood born virus (e.g., HIV, AIDS). This will be confirmed via questioning at screening and will be self-reported.

Known allergies to any cosmetic ingredients.

Overly sensitive to blood sampling procedures.

Any subjects presently taking prescription medications

Subjects requiring anti-inflammatory medication

Individuals with any relevant past or present medical history or are prescribed medication which may affect the study results or may lead to increased risk to the subject in the judgment of the medical investigator.

Individuals who are taking part in another clinical trial.

Individuals who are employees of Unilever or the CRO.

Any subject who has a score of 2.0 or above for dryness/erythema on the scale detailed in section 3.6.

Study Restrictions

Subjects will be requested to observe the following restrictions during the course of their participation in the study:

During the study subjects will be requested;

Not to change brands of any products currently used or not to use any new products other than the study product during the study.

Subjects will be requested to use the study product once daily at home at the time specified in place of their normal facial moisturiser and/or anti-ageing product.

Subjects should not apply any other leave-on skin products e.g. facial moisturiser, oil or serum for the duration of the study.  Make-up is permitted but only after daily study product application

For the duration of the study where possible subjects should not take/use any aspirin or anti-inflammatory medication. Paracetamol is permitted but not prior to blood sampling on the days which the subject is visiting the test centre.

Expenses

You will be paid a £230 cheque in your name on completion of this study.

How to Apply

To take part in this study please call 08007561046.