212469

Dry Scalp Study

Study Summary

The purpose of this study is to compare the effects of an anti-dandruff shampoo on the health of the scalp. 

Study Overview

 

This study will last up to 11 weeks with eight visits to the test centre in total.

  • Visit 1:                 Screening Visit including Scalp Assessment
  • Visit 2:                 Re-qualification visit with a Scalp Biopsy and Buffer Wash collection 
  • Visits 3,4,5,6:   Four salon visits including a Scalp Assessment followed by a Hair Wash
  • Visit7:                  Final Scalp Assessment including a Scalp Biopsy and Buffer Wash collection
  • Visit 8:                 Final visit for Wound Healing Check (Visit 8). 

At this screening visit your scalp will be assessed to determine if you are eligible for one of the two study groups; Visible Dandruff (Group A) or Visibly Healthy (Group B).  If you are accepted onto either of these groups, you will be required to perform a 4-week wash-out period where you will use a standard beauty shampoo and optional conditioner provided by the test centre.  You will be given a return appointment for Visit 2.

If at requalification (Visit 2) if you are still eligible for either group; Visible Dandruff (Group A) or Visibly Healthy (Group B), you will continue onto the test-phase of the study.  Your scalp will then be visually assessed by test personnel to establish if you still meet the study criteria.  If not, you will be provided with a cheque for £65 for your participation in the first two visits.

Visit 2 – Re-qualification by Visual Assessment, Biopsy, Buffer Wash Sample

If you are eligible to continue with the study a scalp biopsy will be taken from a suitable location on your scalp. The Scalp Biopsy procedure and wound healing will be carried out by a GMC Registered Doctor.  If you are in Group A this will be taken from a site on the scalp with an abundance of dandruff present; if you are in Group B, the biopsy will be taken from a site on the scalp with little or no dryness.   These biopsies will be analysed to check the health and structure of the skin and hair follicle. If selected, you will be asked to sign an additional biopsy consent form which is standard medical procedure. A local anaesthetic will be administered to the area of scalp identified for biopsy collection and checked to confirm it is appropriately anaesthetised. One 4mm, full thickness (4mm depth and width) punch biopsy will then be taken from the site. The wound sites will then be sutured before being cleansed post operatively. A check that any bleeding has stopped will be carried out before application of a sterile dressing, and you will be given a post-operative advice sheet.

Additionally, at this visit a Buffer Wash Collection will be performed.

Visits 3-7

At this visit a scalp assessment will take place followed by your first salon hair wash with the test shampoo and conditioner.  You will be provided with a shampoo and optional conditioner to use at home over the next 4 weeks, twice weekly.  This will be the same product as those applied at the test centre. You will return weekly for Visits 4, 5 and 6 at which the same procedures as Visit 3 will take place.  During the test phase you must attend the set dates for your group to ensure the study products are applied to the correct schedule.

You will be asked to return the following week for Visit 7.  No salon wash will be performed however you will have a scalp assessment. The procedures at Visit 2 will then be repeated.  A scalp biopsy will be taken from a suitable site on your scalp; both groups will have the biopsy taken from a site on the scalp with little or no dryness.  Following this a Buffer Wash Collection will be taken from a suitable site on the scalp. The Biopsy and Buffer Wash Samples will be taken from different sites to those collected at Visit 2.

For ALL VISITS, you must wash your hair approximately 48 hours (± 4 hours) hours prior to your Visit 2 appointment.

Visit 8 – Biopsy Wound Check

 

This visit will take approximately 30 min, in duration. You will be asked questions to ensure your compliance with the study requirements and any changes to your medical history.  A wound healing check will be performed.

Hair Cut/Hair Dye – Restrictions

 

You must not cut or dye your hair 2 weeks before your screening visit.

You CAN have your hair cut/dyed from visit 3 until 48 hours before visit 5.

You CAN also cut/dye your hair from visit 7 onwards with medics approval.

Attendance – Visits

Screening Visit – Please choose ONE visit below. This visit will take approx. 1 hour and 15 minutes.

 

Monday 24 September 2018 – Appointments will run from 9am – 4pm

Tuesday 25 September 2018 – Appointments will run from 9am – 4pm

Wednesday 26 September 2018 – Appointments will run from 9am – 4pm

Thursday 27 September 2018 – Appointments will run from 9am – 4pm

Friday 28 September 2018 – Appointments will run from 9am – 4pm

 

At visit 2 you will be assessed to see if you are eligible to carry on with the study:  if at the point if you are not eligible you will receive £65 expenses for your participation in this study.

 

 

Once you have attended your screening visit you will choose one of the groups below that you would like to join for the main study.

 

Appointments will run from 9am – 4pm.

Cohort -

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Approx. appointment times

Visit 2

Assess, Buffer, Biopsy

Monday 22 Oct 2018

Tuesday 23 Oct 2018

Thursday 25 Oct 2018

Friday 26 Oct 2018

This visit will take 2 hours.

Visit 3

Wound Check, Assess & First Hair Wash

Monday 05 Nov 2018

Tuesday 06 Nov 2018

Thursday 08 Nov 2018

Friday 09 Nov 2018

This visit will take 1 hour and 15 minutes.

Visit 4

Assess, Hair Wash

Monday 12 Nov 2018

Tuesday 13 Nov 2018

Thursday 15 Nov 2018

Friday 16 Nov 2018

This visit will take 1 hour.

Visit 5

Assess, Hair Wash

Monday 19 Nov 2018

Tuesday 20 Nov 2018

Thursday 22 Nov 2018

Friday 23 Nov 2018

This visit will take 1 hour.

Visit 6

Assess, Hair Wash

Monday 26 Nov 2018

Tuesday 27 Nov 2018

Thursday 29 Nov 2018

Friday 30 Nov 2018

This visit will take 1 hour.

Visit 7

Assess, Buffer, Biopsy

Monday 03 Dec 2018

Tuesday 04 Dec 2018

Thursday 06 Dec 2018

Friday 07 Dec 2018

This visit will take 1 hour.

Visit 8

Wound Check, Completion of Study

Monday 17 December 2018/ Thursday 20 December 2018

Thursday 20 December 2018/ Friday 21 December 2018

This visit will take 2 hours.

 

Inclusion Criteria

The following Inclusion Criteria will be used during subject recruitment: 

 

 

  1. Female
  2. Caucasian (Fitzpatrick I – III)
  3. Aged 18 to 55 (inclusive) at baseline visit
  4. Scalp condition assessed as having visually healthy scalp; with no lesions after 4-week washout with beauty shampoo.
  5. Scalp condition assessed as dandruff, after 4-week washout with beauty shampoo.
  6. Hair length long enough to be held in place by hair grips during sample collection, and long enough to cover biopsy sites. Usually > 5cm (in the opinion of study personnel).
  7. Scalp free from cuts, abrasions, pustules and tattoos.
  8. Subjects willing only to use the study shampoo provided and to comply with instructions of no alcohol, no strenuous exercise (e.g. Gym) or swimming within 24hours prior to sample collection visits.
  9. Female subjects using a hormone based method of contraception (including but not limited to: oral, medicated IUD, injection, or implant). 
  10. Willing to not take part in any hair or scalp study for any other company for the duration of the study.

Exclusion Criteria

The following Exclusion Criteria will be used during subject recruitment: 

 

 

  1. Pregnancy within the previous 12 months, or currently breast feeding.
  2. Any history of serious illness that may affect the outcome of the study
  3. Any history of cancer at any time
  4. Use of immunosuppressive drugs; e.g. methotrexate, cyclosporine, prednisone
  5. Has any known immunological disorder (including, but not limited to, hepatitis, HIV+, AIDS, systemic lupus erythematosus)
  6. Regular use of medication that may affect the outcome of the study
  7. Currently taking or taken within 2 weeks of sample collection, any anticoagulant medication (e.g Warfarin), anti-platelet medication (e.g. clopidogrel) or be taking regular aspirin
  8. Known allergy to anaesthetics such as lidocaine, xylocaine with adrenaline, lidocaine with ephedrine, or topical antibiotics such as Neosporin.
  9. Family history of delayed wound healing or have formed keloids as a result of wounds in the past
  10. History of blood clotting disorders or any problems with excessive bleeding
  11. Hair loss (Savin 2 or over) or any history of hair loss for medical reasons, including, but not limited to, alopecia areata, alopecia universalis, alopecia totalis or telogen effluvium
  12. Current treatment by a doctor for an active skin condition (any body site)
  13. Sufferers of eczema or psoriasis on any area of head, neck, face or hands during adult life (age 18+)
  14. Current use of topical steroids on the scalp
  15. Current use of inhaled or systemic steroids
  16. Users of ketoconazole-based shampoo (Nizoral, Neutrogena Long Lasting) or selenium sulphide based shampoo (Selsun, L’Oréal Intensive, Head & Shoulders Intensive) in the last 3 months
  17. Current use of anti-inflammatory, antibiotic, antifungal or antihistamine medication
  18. Any severe febrile illness within the last 4 months (record date if known)
  19. Very tight curly hair (difficult to hold into a parting)
  20. BMI over 35
  21. Permed, dyed or coloured hair within 2 weeks of screening
  22. Known allergies or sensitivity to shampoo, or sample collection ingredients
  23. Subjects on extremely restrictive diets such as low protein or Atkins diet (subjects on gluten free diets can be accepted)
  24. Subjects currently on or recently finished an extremely low calorie diet (<1000 calories a day).  This includes diets such as the 5:2 diet.
  25. People who regularly drink more than the government daily unit guidelines of 2-3 units of alcohol for women (equivalent to a 175 ml glass of wine). ‘Regularly’ means drinking every day or most days of the week
  26. Shift workers (diurnal rhythms will be abnormal)
  27. Visible evidence of head lice
  28. Recent tattooing (within the last month)
  29. Currently suffering from any back or neck problems, which may hinder sample collection

Study Restrictions

Subject Restrictions:

 

 

Subjects will be asked to use only the beauty shampoo and conditioner with which they have been provided for up to four weeks prior to a re-qualification visit, and an anti-dandruff shampoo for a further four weeks.

All subjects selected to participate in the study will be asked to wash their hair with the shampoos with which they have been provided 48 ± 4 hours, and not to wash their hair again, before scalp assessment and scalp sampling visits.  Subjects will also be asked not to use any products, including styling products, on their hair during this period.

For 48 hours prior to each sampling visit, subjects will be asked not to drink alcohol, go swimming or wet their hair.

Subjects must follow the scalp and hair care instructions provided to them by the study doctor following biopsy collections.

Expenses

If you complete visit 1 & 2 and are not eligible to take part in the main study you will receive £65 Expenses. 

If you complete all 8 visits you will receive £300.00 expenses.

You will receive a cheque in your name on completion of this study.

How to Apply

To take part in this study please email recruitment@albavolunteers.com, if you know anyone else who would like to take part please forward this email to them – once you have read all of the study information.