213763

Male Grooming Hair Removal Study (Group 3 & 4)

Study Summary

Alba Science is inviting you to take part in a research study where we will test 2 variants of a chemical depilatory cream (hair removal cream)-(variant 3 - sensitive and variant 4 - normal) on marked out areas of your lower legs and each underarm.  You should be aware that during this study, our intention is to REMOVE the hair from areas of your lower legs and underarms. 

If you are uncomfortable with the after-effects of this procedure i.e. HAIRLESS at test sites until regrowth – you should not participate. 

The products being tested, are 2 variants of a depilatory cream, from a range intended for the male consumer market.  Historically, clinical data for male depilatory cream usage has been generated in female subjects, for this dedicated male range development, our Sponsor would like to obtain data in a male panel.

The study objective is to evaluate how effective the 2 variants (3 & 4) of the depilatory cream are at hair removal when applied for various times on the lower legs of a male panel of volunteers. 

During the study we will also evaluate the following characteristics on the lower legs:

·       Skin moisturisation

·       Tolerability of the products

Each variant of the depilatory cream (3 and 4) will be compared against shaving, using a male 3-blade razor.

In addition to the evaluations performed on your lower legs, we shall also assess the tolerability of each of the two variants (3 and 4) when applied to your underarms.  The variants will be applied according to the on-pack application times (between 3 and 7 minutes, respectively).

Study Procedures

 

Visit 1:  Day-4 to Day-6)

At the first visit you will have been asked to attend for this visit, having refrained from using any products (excluding washes) on your lower legs in the last 24 hours. 

We will explain the study to you, answer your questions and if you are willing to take part, ask you to sign two copies of an informed consent form (ICF).  We will then ask you some questions about your health and medications. Part of the selection process involves an assessment of your lower legs and underarms by the study team to ensure that it is free from any active skin condition, birthmarks, scars or tattoo(s).  We will also ensure that you have sufficient hair at both test areas; legs and underarms.  It may be that we are unable to accept you onto the study based on these visual examinations, or the responses you give to the screening questionnaire.  If you are not accepted onto the study, then you will receive a £5 payment in the form of a cheque for your visit.

If you do match the criteria and are accepted onto the study, you will be provided with a specific appointment time and asked to return to the test centre on study Day 0.

VISIT 2:  Day 0 – Approx. 4.5h

Lower Leg Procedures

The hair on the lower legs will be trimmed to approx. 5mm length. You will then be asked to acclimatise for a minimum of 20 min in an environmentally controlled room, with your lower legs exposed (it would be helpful if you wore shorts at this visit).

During acclimatisation, 7 test sites of 5cm x 10cm will be marked on your lower legs.  One leg will have 4 sites marked out (2 on the inner and 2 on the outer leg), whilst the other leg will have 3 sites marked out, 1 area on the inner leg and 2 on the outer area.  The test sites will be delineated by marking the leg with a semi-permanent felt-tip pen.

After the test sites have been delineated baseline macrophotographs (using a Nikon digital camera), visual irritation, hair counts and Corneometer assessments will then be performed.  A Corneometer is an instrument designed to measure skin hydration, it consists of a flat probe which is gently placed on the skin to provide a measurement of moisture content. 

The test products (variants 3 & 4) will be applied to each of the randomised test areas on the legs by ALBA test personnel, and then removed with a spatula according to the manufacturer’s instructions.   The test product residue will be removed from the test areas, by rubbing each individual area with a washcloth, in a circular motion.

We will ask your perception of product tolerance (burning and stinging sensations) during hair removal. 

All leg assessments (macrophotographs, visual irritation, hair counts, and corneometer assessments - together with your own and test personnel tolerance assessments - will be repeated 30 minutes after hair removal.

Underarm Procedures

On completion of leg procedures, you will immediately undergo the underarm testing.  Prior to application of the test variant product, you will be requested to wash both underarms using Dove body wash. You will rinse, each underarm under running lukewarm water and blotted dry, using paper towels.  Your underarms will be allowed to air dry for approx. 10 min, after which we will apply the 2 test variants, one per underarm.  You will be reclining (lying down on a treatment bed) during application of the test products.  We will spread the test product evenly over the test area, covering all hair.   We shall take care to limit the area of application of the test product, to the visibly hairy part of the underarm, as far as possible.

The variants will be applied according to each variant on-pack application times (5 and 3 minutes, respectively) and removed with the plastic spatula.  On completion, each underarm will be rinsed with lukewarm water (~25°C) until no traces of depilatory cream remain and blotted dry using paper towels.

We will ask your perception of product tolerance (burning and stinging sensations) during hair removal and 30 min later. In addition, tolerance assessments will be performed by test personnel, 30 minutes after hair removal.

An appointment time will be arranged for the next day approx. 24h after product removal, study day 1.  You will be requested to keep the skin markings delineating the test areas in place until your next visit.

 

VISIT 3:  Day 1 – Approx. 1 hour

You will have been asked to refrain from using any products (excluding washes) on your lower legs in the last 24 hours.  You will be questioned about your general health, changes to any medication(s) and compliance with the study requirements. 

You will then acclimatise for a minimum of 20 min in an environmentally controlled room, before skin assessments (legs and underarms) are performed and Corneometer measurements captured.

We will ask your perception of product tolerance (burning and stinging sensations) and perform tolerance assessments by test personnel.

After this final assessment, volunteer expenses of £100 will be provided in form of a cheque made out in your name.

 

Attendance

You will be required to attend 3 visits to our Broughton Street test centre.

Group 3

Screening Visit

Tuesday 30 July 2019

Appointments running from 9am – 1pm

Approx. 1 hour.

Visit 2

Thursday 01 August 2019

Appointments running from 9am – 5pm

Approx. 4 hours and 30 Minutes.

Visit 3

Friday 02 August 2019

Appointments running from 9am – 5pm

Approx. 1 hours.

OR

Group 4

Screening Visit

Monday 29 July 2019

Appointments running from 2pm – 4pm

Approx. 1 hour.

Visit 2

Tuesday 30 July 2019

Appointments running from 9am – 5pm

Approx. 4 hours and 30 Minutes.

Visit 3

Wednesday 31 July 2019

Appointments running from 9am – 5pm

Approx. 1 hours.

Inclusion Criteria

Subjects must be:

Healthy male subjects aged between 18 and 55 years

Subjects with dark hair colour on your legs and underarms as this will be easier for our hair count.

Subjects who are able to give informed consent and from whom written informed consent, including a confidentiality undertaking, has been obtained

Subjects assessed by a dermatologist as having sensitive/dry or sensitive/not dry skin

Subjects who are able to understand the study, co-operate with the study procedures (including the restrictions stated in Section 7) and are able to attend for all study assessments.

Exclusion Criteria

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

subjects who have depilated and/or shaved their lower legs within the previous 10 days or who have waxed/epilated their lower legs within the previous 3 weeks

Subjects with very Light coloured hair as this will be difficult for the hair count.

subjects who have shaved or used chemical depilatory products on their underarms in the previous 72 hours

subjects with active psoriasis or with a history of psoriasis

subjects with active skin disorders or with a history of skin disorders within the previous 2 years, which in the opinion of ALBA’s dermatologist may affect the test results

subjects with a history of skin tumours or malignant disease

subjects taking antihistamine or steroid preparations, any medication for the treatment of diabetes mellitus, immuno-suppressive drugs or any other medication which in the opinion of ALBA’s dermatologist may affect the test results

subjects who have had an organ transplant or who have had axillary lymph nodes removed

subjects who are suffering from chronic asthma, a malfunction of the lymphatic system, or an auto immune deficiency disease (e.g. lupus, thyroiditis)

subjects who have previously experienced an irritant or allergic reaction to any depilatory product

subjects who have participated in any similar skin test within the previous month

subjects who have used any products (excluding washes) on the lower legs in the 24 hours prior to the study start

subjects who have used any topical product (drugs, cosmetics or deodorants) on the underarm within 12 hours prior to the study.

subjects who are employees or who work for a manufacturer of personal care products or for the testing facility.

Study Restrictions

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

not smoke or use tobacco products 1 hour prior to the visit(s) or during the visit(s). This includes the use of E-cigarettes

not to consume any hot drinks/food (unheated foods such as sandwiches, rolls, wraps, snacks etc are acceptable), or any caffeine-containing drinks/food (including chocolate) for a period of 1h before starting the study and for the duration of the visit

not cover the test sites whilst in the test centre.

not to sunbathe

not to apply any cosmetic products on the lower legs and underarm test areas until after the Day 1 assessment (24 hours after test regimen use) has been performed

to avoid rubbing the lower legs when drying the skin until after the Day 1 assessment (24 hours after test regimen use) has been performed

not to remove hair from the lower legs over the study period (other than the hair removal performed for study purposes)

not to use any exfoliating or hair regrowth inhibitor products on the lower legs

not to apply other cosmetic products to the lower legs until the Day 1 assessment (24 hours after test regimen use) has been performed

not to otherwise change cosmetic products (e.g. moisturiser) used on the lower legs over the study period

Expenses

You will be paid a £100 cheque in your name on completion of this study.

How to Apply

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