We are pleased to inform you about our next study at the Surrey Clinical Research Centre (Surrey CRC) in Guildford. We are currently looking for healthy males and females to take part. The aim of the study is to assess the effectiveness of a new alcohol skin wipe.
This study involves 3 visits. First visit you will be required to attend and pass a medical screening session to be considered for a place on the study – this will last approximately 2 hours. You will then undergo a 14 day conditioning period at home where you will be required to only wash with water, and must not rub the sites during washing. You will not be allowed to wash your hair with shampoo or conditioner (including dry shampoo and conditioner), you will only be able to wash your hair with water. You will be able to use the non-medicated personal hygiene product (soap to wash your hands and feet) provided to you at your screening visit. After using the soap, you must rinse your hands thoroughly. If you leave the house you will need to take the soap provided to wash your hands.
You are not allowed to use perfume, deodorant, shampoo, conditioner or moisturiser (except on your face) during this period. If you use moisturiser on your face, you must remove this using a damp flannel before bathing/ showering. You will be given a diary card to confirm you are following the restrictions.
You will be able to wear make up only on your face. However you will need to remove this using eye make-up remover pads. If you use the eye make- up remover pads, you must rinse your face with a damp flannel before you get in the shower. The damp flannel can also be used to remove make up from the rest of your face. .
You will be required to wear clothing washed only in water during this period, your bedding and towels must also be only washed in water.
You must wear loose fitting clothing (no lycra or skinny jeans would be allowed) and you must wear the boxer briefs, which can be provided by Surrey CRC if required.
After the 14 days you will attend a second screening visit lasting approximately 2 and a half hours where you will have samples taken from the surface of your skin to record your baseline bacteria levels (visit 2). The test site areas are the arm, clavicle, abdomen and groin. The test site areas must not have any sign of damage or irritation to the skin and we would advise not to the shave or wax these areas from Day -18 until your visit 2 appointment to avoid this. After this visit, if you satisfy all our criteria you may be chosen to continue on to the study.
You will be prohibited from showering and bathing with water, using perfume, deodorant, shampoo, conditioner or moisturiser (except on your face) from this visit (Day -5) until your residential stay (Day 0/1). You will be able to wash your hands with the soap provided. You will be able to wear make up on your face only. However you will not be able to use any make up remover.
If you leave the house you will need to take the soap provided to wash your hands. You must continue to wear loose fitting clothes and boxer briefs, wash your clothes, towels and bedding with only water.
You will be informed of your eligibility on Day -1. If you are eligible based on the bacteria level at abdomen and/or groin only then your visit 3 will last approx. 8 hours, if you are eligible at the clavicle and/or arm sites then your visit 3 will last approx. 27 hours.
You will be assigned randomly to one or more of three groups looking at comparing two different treatments e.g you could be randomised into Group 1 for your arm, and group 2 for your collar bone.
Group 1 will compare the new alcohol wipe with a placebo wipe (of saline solution); group 2 the new alcohol wipe with an existing licensed product; and group 3 the existing licensed product with placebo. 5 days after visit 2 you will attend for your final visit (visit 3). At this visit one of the treatments will be applied at your eligible site/s on one side of your body, and the other treatment applied to the same eligible site/s on the opposite side of your body. Samples will be taken from the surface of your skin at each of these sites at set time points to measure microbial levels on your skin. The study procedure on Day -5 and Day 0 involve the exposure of intimate areas and these areas being clipped for hair, swabbed with the study product and samples being taken. We will provide coverage for these areas but we are unable to assign gender specific staff to take your samples, however a chaperone will be provided if requested. The utmost care will be taken to ensure that your privacy is maintained.
To be eligible to take part you must:
- Be a healthy male or female aged 18-70 Years.
- Be willing to refrain from using topical antimicrobial agents, sunbathing and sunbeds while on the study (to be advised at screening).
- Have no known allergies to latex, alcohols or common antibacterial agents.
- Clear of any skin rashes, skin diseases or inflammatory skin conditions.
- Agree to only wash with water from Day -18 (Screening) to Day -5 (Visit 2).
- Agree to wear clothes and use bedding that has been washed in water only. You must refrain from using any washing powder or fabric softener.
- Happy to refraining from washing for 5 days (From Day -5 to the end of the study).
- Agree not to wash your hair with any products (shampoo, conditioner, dry shampoo, dry conditioner etc) for the duration of the study. You will be able to wash your hair with water only up to Day -5 (Visit 2)
- Have not taken part in another clinical trial in the past 3 months.
- Be available for the duration of the study (approximately 3 weeks).
Visit 1 – Screening – approx. 2 hours
Visit 2 – Outpatient visit – approx. 1 hour
Visit 3 – Overnight residential visit – approx. 27 hours
If your Visit 3 lasts approx . 8 hours and you are not required to stay overnight then you will be reimbursed £700; if your visit lasts approx. 27 hours, you will be reimbursed £825.
If you have already registered with us or have previously taken part in a study at the CRC please click "already registered" to express your interest. If you have not previously registered please click "new participant application form".
If you would like more information under no obligation, please contact the recruitment team on: 0800 269 847 or email firstname.lastname@example.org.
This study has been approved by an Independent Research Ethics Committee.