212755

6 Week Moisture Study For Dry Skin On Legs

Study Summary

Alba Science invites to participate in a 6 week moisture study.

Purpose of the Study

The purpose of this study is to increase understanding of cosmetic dry skin conditions and to evaluate the effects of moisturising products on the presence of microflora (bacteria), proteins and lipids (natural oils) present on the skin and on the visible dryness and redness of the skin as compared with a marketed moisturising product or compared with no treatment.

Study Overview

The study will run in 2 phases.

Phase 1 of the study will take place over 1 week and will include 2 visits to the test centre including this screening visit, where we will confirm your eligibility to take part. 

Phase 2 will run over 5 weeks and will include an additional 5 visits to the test centre. 

At this screening visit, you will be asked about your health and medication.  Both your lower legs will be visually assessed to determine the condition of the skin on your lower legs.  It may be that we are unable to take you onto the study based on this questioning and/or examination. 

If you are accepted onto study you will be assigned to one of two Cohorts;

Cohort 1 will include at least 60 volunteers with visually moderate levels of dry skin present on their lower legs.

Cohort 2 will include at least 40 subjects with visually low levels of dry skin on their lower legs. 

Volunteers in Cohort 1 (Dry Skin) will take part in both Phase 1 and Phase 2 of the study

Volunteers in Cohort 2 (Very Low Levels of Dry Skin) will take part in Phase 1 only.

 

You will be provided with a razor for shaving your legs and a diary sheet, which includes appropriate instructions. 

You will return a week later for Visit 2, the Phase 1 Sampling visit, during which the following assessments and procedures will take place.

  • Two of a possible four test sites (9x10cm) will be marked on each outer lower leg (left and right).
  • You will be required to acclimatise to environmental conditions with your lower legs exposed for approximately 15 minutes prior to a Visual Assessment of the two test sites for redness and dryness. 
  • Following this, hydration measurements will be taken from 5 areas within each test site using a measuring device (flat probe which gently touches the skin).
  • Cell samples from the skin surface of both your legs will be collected using a washing technique.
  • You will then have two separate types of tape stripping procedures applied to separate chosen areas within each test site, type 1 tape strips (circular adhesive tapes approx. 2.5cm diameter) and type 2 tape strips (rectangular adhesive tapes, 2.5cmx8cm) are applied to the skin to allow sampling of the protein and lipid (fatty) cells from the top layer of the skin.  Up to 20 tape strips will be placed on the same area in the site for each of the tape stripping methods. 
  • Subjects in Cohort 2 (Very Low Levels of Dry Skin) will complete the study after all sampling and instrumental measurements at Visit 2 and will receive study expenses in the form of a cheque.
  • Subjects in Cohort 1 (Dry Skin) will be dispensed up to two test products.  It is completely random which treatment you will receive.  There is an equal chance you can be assigned to any of two products or no treatment (you maybe be allocated a product for each leg or one product with one leg remaining untreated).  You will also receive a diary to record each product applications, cleansing and shaving during the study.  You will be given a razor blade (replaced weekly) to shave your legs.
  • Phase 2 begins immediately and Cohort 1 will be given an appointment for Visit 3.

During Phase 2 you will be asked to return weekly for Visits 3, 4, 5 and 6 which involve visual assessments to allow us to monitor the sites.  Your product will be weighed at each visit and diary sheet checked so you must bring this along with you to each visit for the study duration.

As with Visit 2 you will be required to observe a 48h wash-out, where no products, including the test product(s), are to be applied to the legs prior to Visit 7. The same procedures will be carried out as at Visit 2 but on the remaining, un-sampled sites on each lower leg, left and right.

Please note you must bring ALL TEST PRODUCTS, including empty packaging, and Diary Sheets back to the test centre at every visit.  If you do not return all test products dispensed to you, you will not receive the study expenses.

 

 

Visit Overview

Visit 1 (Day -7) Screening and Consent:

 

You will be asked to read the study information provided in this sheet.  You will be asked to answer questions on your medical history.  Your legs will be assessed to confirm suitability for either Cohort 1 or Cohort 2. If accepted, you will be given a razor and diary sheet with instructions for requirements prior to Visit 2.  You will be given an appointment to attend the following week.

Visit 2 (Baseline) Phase 1 Sampling Visit:

 

You will attend the test centre having observed a 2 day wash out period.  Your compliance and medical history will be checked.  You will then have visual, instrumental and sampling measurements carried out on one of two sites on each leg (two sites will be assessed, one on each leg). If you are in Cohort 1 you will be dispensed test product(s) and immediately begin Phase 2.  You will be given a return appointment for Visit 3.  If you are in Cohort 2, you will now have completed the study and will be given your study expenses in the form of a cheque.

Visits 3, 4, 5 & 6 (Weeks 1, 2, 3, 4) Compliance and Visual Assessments:

 

You will attend the test centre with your product(s) and diary sheet.  Your compliance and medical history will be checked.  The sites on your legs will be visually assessed for redness and dryness.  You will be given a return appointment for each following visit.

Prior to visit 7 you are asked to cleanse and shave your legs to your normal habits up to 2 days before Visit 7 when you will be asked to shower, wash and shave your lower legs a final time before observing a 48h wash-out where no products, including the test product(s), are to be applied to the legs (you may wash with water but you cannot use washing accessories such as a cloth or sponge).   

Visit 7 (Week 5) Phase 2 Sampling Visit:

 

You will attend the test centre having observed a 2 day wash out period.  Your compliance and medical history will be checked.  You will then have visual, instrumental and sampling measurements carried out on the remaining, alternative site not sampled at baseline on each leg (two sites will be assessed, one on each leg).  Once all Visit 7 measurements have been completed you will receive your study expenses in the form of a cheque.

Attendance – 2 or 7 Visits

You must be available to for all 7 visits below appointments are running from 9am

 

Please choose which group you would prefer otherwise we will allocate what we have available.

 

Group 9 - Phase 1

Date

Length Of Appointment

Visit 1

Monday 22 May 2017

This visit will take approx. 45 minutes.

Visit 2

Monday 29 May 2017

This visit will take approx. 3 hours.

 

 

 

Group 9 - Phase 2

Date

Length Of Appointment

Visit 3

Monday 05 June 2017

This visit will take approx. 30 minutes.

Visit 4

Monday 12 June 2017

This visit will take approx. 30 minutes.

Visit 5

Monday 19 June 2017

This visit will take approx. 30 minutes.

Visit 6

Monday 26 June 2017

This visit will take approx. 30 minutes.

Visit 7

Monday 03 July 2017

This visit will take approx. 3 hours.

Group 10 - Phase 1

Date

Length Of Appointment

Visit 1

Tuesday 23 May 2017

This visit will take approx. 45 minutes.

Visit 2

Tuesday 30 May 2017

This visit will take approx. 3 hours.

Group 10 - Phase 2

Date

Length Of Appointment

Visit 3

Tuesday 06 June 2017

This visit will take approx. 30 minutes.

Visit 4

Tuesday 13 June 2017

This visit will take approx. 30 minutes.

Visit 5

Tuesday 20 June 2017

This visit will take approx. 30 minutes.

Visit 6

Tuesday 27 June 2017

This visit will take approx. 30 minutes.

Visit 7

Tuesday 04 July 2017

This visit will take approx. 3 hours.

 

Group 11 - Phase 1

Date

Length Of Appointment

Visit 1

Wednesdy 24 May 2017

This visit will take approx. 45 minutes.

Visit 2

Wednesday 31 May 2017

This visit will take approx. 3 hours.

Group 11 - Phase 2

Date

Length Of Appointment

Visit 3

Wednesday 07 June 2017

This visit will take approx. 30 minutes.

Visit 4

Wednesday 14 June 2017

This visit will take approx. 30 minutes.

Visit 5

Wednesday 21 June 2017

This visit will take approx. 30 minutes.

Visit 6

Wednesday 28 June 2017

This visit will take approx. 30 minutes.

Visit 7

Wednesday 05 July 2017

This visit will take approx. 3 hours.

 

Group 12 - Phase 1

Date

Length Of Appointment

Visit 1

Thursday 25 May 2017

This visit will take approx. 45 minutes.

Visit 2

Thursday 01 June 2017

This visit will take approx. 3 hours.

Group 12 - Phase 2

Date

Length Of Appointment

Visit 3

Thursday 08 June 2017

This visit will take approx. 30 minutes.

Visit 4

Thursday 15 June 2017

This visit will take approx. 30 minutes.

Visit 5

Thursday 22 June 2017

This visit will take approx. 30 minutes.

Visit 6

Thursday 29 June 2017

This visit will take approx. 30 minutes.

Visit 7

Thursday 06 July 2017

This visit will take approx. 3 hours.

 

 

If you are only selected for phase 1 you will receive £50 expenses at this stage.

If you complete all 7 visits you will receive £100 expenses.

Inclusion Criteria

The following Inclusion Criteria will be used during subject screening and recruitment:

Aged 18 to 50 years

Female.

Fitzpatrick skin type I-III (Fair Skin)

In general good health.  

BMI 18.5-34.9 (inclusive)  

Must have dry skin on your legs.

Willing and able to read and sign an Informed Consent Form, comply with the study restrictions, and carry out all study procedures. 

Only use the study products that are provided on their lower legs.  

Remove leg hair using a razor. 

Exclusion Criteria

The following Exclusion Criteria will be used during subject recruitment:


Must not be menopausal, post-menopausal or using any form of HRT.

Must not have a history of serious illness that may require regular systemic medication (e.g. liver dysfunction)  which may influence the study outcome.

Must not have a history of any type of cancer in the last 5 years.

Must not have any immunological disorder (including, but not limited to, hepatitis, HIV+, AIDS, systemic lupus erythematosus, rheumatoid arthritis, hepatitis).

Must not have a history of any dermatological condition on the leg in adult life; e.g. eczema, psoriasis, ichthyosis, atopic dermatitis.

Must not be diabetic.

Must not be using any immunosuppressive drugs; e.g. methotrexate, cyclosporine, prednisolone for the two months prior to the start of the study or if has started taking these medications during the study.

Must not have used any antimicrobial drugs; e.g. penicillin, cephalosporins, tetracyclins, fusidic acid for the two months prior to the start of the study.

Must not be using any lipid lowering medication (e.g. statins) for two months prior to the start of the study.

Must not be using any steroidal medicine (inhaled, oral or topical).

Must not be using any topical medication on the lower outer leg.

Must not be using systemic anti-inflammatory medication on a frequent basis (at the discretion of the medical monitor).

Must not have a suspected allergy to soap, shower gel, moisturising products or any product containing yeast as well as any alcohols (Such as rubbing alcohol or isopropanol).

Must not have excessive erythema or excoriations on the lower leg.

Must not have test sites with tattoo, scars or any other features that may affect the study procedures. 

Must not be currently pregnant or breast feeding (based on self- report only), or has given birth to or breast fed a child within the last 12 months. 

Must not be using sunbeds or sun-showers in the month prior to the start of the study, or using one during the study or planning a holiday in the sun during the study.

Must not be currently suffering from any problems with the back, hips or legs that would make sampling from the lower outer leg excessively uncomfortable for the subject or logistically difficult for the study team.

Must not be have any allergy to plasters/adhesive tape.

Must not be current smokers.

Be participating currently or have participated (within the last 4 weeks) in any other study involving the legs at this test facility or anywhere else.

Study Restrictions

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

SUBJECT MUST AGREE TO THE FOLLOWING: 

Subjects will not be able to use any other moisturising products on their lower legs during the study such as tanning lotions, creams, bath oils, additives, sunscreens, after sun products or any other skin care product during the 5 week test period.

They can however continue to use their own cleansing product (soap or shower gel in their normal manner) up to 2 days ((± 4 hours) prior to sampling (at both baseline and week 5).

Details of all products will be recorded in the subject diary.

Subjects will be provided with a marketed razor (replaced weekly) with which to shave their lower legs during the study.   

At 48 hours (± 4 hours) prior to sampling subjects will be asked to shower, wash and shave their legs with their own cleansing product and with the razor provided.

Following this shower, the following restrictions will apply:

Not to go swimming or use saunas/steam rooms or similar.
Not to shave their legs again.
Not to apply any products to their legs (this includes test product, hair shampoo or cleansing product during this 48 hour period).
Prior to measurements on the legs, subjects will be requested not to consume spicy foods, hot/very cold drinks, green tea, cranberry juice or any food or drink containing caffeine for up to one hour before attending.
They must also not consume any alcohol for 12 hours prior to measurement.   

 

If a subject wishes to take a shower during this 48 hour washout period they must do so preferably the night before their visit or at least 3 hours prior to the study visit. N.B when showering water can run over the leg only (no rubbing is to be involved).   

Subjects will be asked to wear clothing such that their lower outer legs are accessible to each study visit; e.g. if wearing long trousers, subjects will be asked to roll trouser legs up for the duration of their study visit.     

This wash out period of 2 days will apply to both the baseline and week 5 visit.  

Expenses

You will be paid a £50 cheque or £100 cheque in your name on completion of this study depending on how many visits you do.

How to Apply

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