213987

Laser Hair Removal Study

Study Summary

You are invited to participate in a laser hair removal study. The study duration will be 106 days (15 weeks), with total number of 13 visits to the test centre. 

We will be using 2 different commercially available light-based treatments (Intense Pulsed Light (IPL) & Laser devices) at varying settings. A control lotion without the active ingredient will be included in the test for comparison.

Please do not shave your legs before your visit as we need to see visible leg hair even if it’s very short.

The panel will be recruited so that there are 4 equally sized hair colour groups, classified as natural hair colour (on the leg).

Black or Dark brown hair – This Category is now full

Blonde hair -

Any shade of Red hair -

Grey or Very Light blonde/White Hair

 

During the study, digital images from your lower legs will be captured for hair count analysis, and visual grading and instrumental assessments will be performed on 9 test sites which will be marked out on the outer lower legs between the ankle and the knee.

Study Procedures

Firstly, you will go through the screening procedures the purpose of which is to determine whether 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 male or female, Caucasian, have a pale complexion, be in good general health and be aged 18-70. The skin on your legs must be free from remarkable moles, tattoos, cuts, scratches, abrasions or open wounds. In addition, you must be able to lie on your back on a bed for approximately 45 minutes to enable assessment of the test areas, the instrumental readings, product application and instrumental hair removal to be performed (when required).

You should not be taking any regular medication which may influence the response of the skin, e.g. anti-inflammatory medication, corticosteroids or antihistamines and you should not be using topical medicines or emollients on your legs.

You should be available to attend the study site between the allocated study hours for all visits.

If you are pregnant or think that you may be, or you are currently breast feeding, you must not take part in this study.

In any of these instances please hand the paperwork back to the study staff. You do not have to give a reason for not taking part.

Attendance

Screening Visit

 

Tuesday 21 January 2020 or Wednesday 22 January 2020 – Appointments will run from 9am – 4pm – This appointment will take approx. 1 hour.

Main Study Dates Below:

 

GROUP 3

Visit 2

Tuesday 28 January 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 3

Tuesday 04 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 4

Tuesday 11 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 5

Tuesday 18 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 6

Tuesday 25 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 7

Tuesday 03 March 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 8

Tuesday 10 March 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 9

Tuesday 17 March 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

Visit 10

Tuesday 31 March 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 11

Tuesday 07 April 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

Visit 12

Tuesday 28 April 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 13

Tuesday 05 May 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

 

OR

GROUP 4

Visit 2

Wednesday 29 January 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 3

Wednesday 05 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 4

Wednesday 12 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 5

Wednesday 19 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 6

Wednesday 26 February 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 7

Wednesday 04 March 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 8

Wednesday 11 March 2020

Appointments will run from 9am – 2:30pm

This appointment will take approx. 2 hours and 30 minutes.

Visit 9

Wednesday 18 March 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

Visit 10

Wednesday 01 April 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 11

Wednesday 08 April 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

Visit 12

Wednesday 29 April 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 30 minutes.

Visit 13

Wednesday 06 May 2020

Appointments will run from 9am – 4pm

This appointment will take approx. 1 hour.

 

 

 

 

Inclusion Criteria

Subjects must be:

Males and Females

Age 18-70

Caucasian

Must be in generally good health, as determined by the medical history questionnaire.

Females of no childbearing potential or females, who routinely use adequate contraception prior to and during the study and agree not to attempt to become pregnant during the study.

Subjects with the relevant hair colours in the region of treatment.

Subjects without remarkable moles, tattoos, scars, freckles in the region of treatment.

Subjects must have sufficient terminal hair in the treatment areas, as deemed by test personnel.

Subjects who are able to understand the study,  co-operate with the study procedures (including the restrictions) and are able to attend all study assessments.

Able to communicate well with the investigator and to comply with the requirements of the entire study.

Willing to refrain from shaving, waxing or using any depilatory cream lotions, creams, powders or other skin preparations on the skin on the legs for the duration of the study.

Exclusion Criteria

The following Exclusion Criteria will be used during subject recruitment:

Those suffering from any medical condition or skin disease which,  in the opinion of the test personnel,  will automatically exclude them from participating in the study.

Those with insulin-dependent diabetes mellitus and other diseases that might cause neuropathy.

Prior treatment within the last 3 months, with a laser or IPL hair removal system or electrolysis in treatment areas.

Those who have epilated,  waxed or used hair removal depilatory creams in treatment areas within the last 3 months.

Those suffering from varicose veins in the treatment areas.

Subjects taking drugs that might react as photosensitiser (e.g. amino-levulinic acid,  tetracyclines).

Regular intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants and antihistamines) within 30 days before the beginning of the study as well as during the study.

Any topic therapy,  which might interact with the light treatment.

Those who are pregnant, breast feeding,  lactating or have given birth within the previous 6 weeks or are planning to become pregnant during the study.

Those who have participated in a safety study utilising the same test sites within the previous 4 weeks.

Those who are currently participating in any clinical study,  which in the judgement of the investigator,  could potentially affect responses in either study.

Those who are unwilling to have photographs taken (if necessary) during the study to record any significant reactions.

Study Restrictions

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

Not to use aspirin, anti-inflammatory drugs, antihistamines or systemic corticoids for the duration of the study (paracetamol is allowed for pain relief).  Subjects are requested to alert test personnel of any changes to medication during this study and are informed that certain medications are an exclusion criterion and may result in their withdrawal from the study.

Not to shave or perform any other kind of hair removal procedures on the treated body areas.

Not to change any body care procedures on the legs.

Do not use any moisturising products on the legs on any of the visits to the test centre.

Wear suitable clothing to make access to the test sites easier for the assessments.

Subjects are requested to keep their other typical routines, especially:

Normal lifestyle habits.

Current dietary habit, no special diet.

Habit concerning body cleansing.

Current sports activities.

Environmental exposures. If exposure is necessary, a high SPF 30+ must be used.

Expenses

You will be paid a £250 cheque in your name on completion of this study.

How to Apply

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