213631

Dandruff Study

Study Summary

Alba Science is inviting you to participate in a clinical research study, the purpose of this study is to compare the anti-dandruff efficacy of an anti-dandruff shampoo when used with either an anti-dandruff conditioner or a non-anti-dandruff conditioner, measured by grading the presence of dandruff flakes over a three-week test phase. 

                                                                         

Study Overview

 

This study will run over five weeks.  The first two weeks are the Pre-Conditioning Phase followed by the Test Phase which runs for three weeks. There will be three visits to the test centre in total, incorporating a Screening Visit (Visit 1/Day -14), a Requalification/Baseline Visit (Visit 2/Day 0) and a Final Assessment (Visit 3/Day 22). 

If at requalification (Visit 2) you are assessed to have a suitable amount of dandruff, you will continue onto the test-phase of the study which involves using the shampoo and one of the two conditioners at home for the duration of the test phase. Allocation of the test conditioner will be random. All volunteers will test the anti-dandruff shampoos and one of two conditioners. Neither you nor the test centre personnel will know which conditioner you are allocated.  At all visits, visual assessments of your scalp will be performed to assess your scalp condition.

You must be in good general health and regularly wash your hair (at least 3 times weekly) and be willing to use conditioner during the test phase of the study.  You must be willing to refrain from having your hair cut or coloured for the duration of the study and you must be prepared not to have chemical straightening or other chemical treatments done on your hair for the duration of the study.

Visit Overview

 

Visit 1 (Day -14): Consent and Screening

This visit will take approximately 1 hour.  You will be asked to provide written consent of your agreement to take part in this study.  If you are accepted onto the study after the health screening procedure, you will acclimatise for 15 minutes and then will undergo a scalp assessment. It may be that we are unable to take you onto the study based on this examination. If you are not eligible to participate following the scalp assessment, you will be given £5 for your attendance.

If you are eligible to continue, you will complete a Questionnaire and will be provided with a marketed shampoo to use in place of your regular product. You will be given an appointment for Visit 2.

 

Visit 2 (Day 0)– Re-qualification and Baseline Assessment 

Please attend the test centre having washed your hair approximately 48 (± 4 hours) hours prior to your appointment.

This visit will take approximately 2 hours. The purpose of this visit is to ensure that you have enough dandruff on your scalp to participate in the study after using the supplied beauty shampoo for the last few weeks.

You will acclimatise for 15 minutes in room conditions before having your scalp assessed by test personnel to establish if you still meet the study criteria.  If not, you will be provided with a cheque for £40 for your participation.

If still suitable, study personnel will take images of your scalp using a specialised camera.  Additionally, a small group of subjects (up to 50 people) will be requested to have a further visual assessment at this visit. Finally, you will be required to complete self-assessed questionnaire and test personnel will dispense your test products (a shampoo and conditioner) with instructions to wash your hair three times weekly over the next three weeks. 

Visits 3 (Day 2) Final Assessment

 

Please attend the test centre having washed your hair approximately 48 (± 4 hours) hours prior to your appointment.

This visit will take approximately 2 hours.  You will acclimatise for 15 minutes in room conditions before the condition of your scalp is visually assessed. You will have more scalp images taken.  If you are within the group with the additional visual assessment this will be performed again at this visit. You will be required to complete another questionnaire and after returning your products and diary sheet, study expenses will be provided in the form of a cheque.

Participation Fee

If you complete the whole study you will receive a payment of £90.00 or £100.00 if you take part in the group for additional assessment. If you attend the screening visit but are not accepted following medical history questions and assessment, you will receive £5. If you attend for the re-qualification visit (Visit 2) of the study, but we decide that you cannot progress, you will receive £40.

Inclusion Criteria

Inclusion Criteria

Healthy male or female

Age 18-65 (Inclusive)

Washes their hair at least 3 times per week

Subject must be willing to:

Use conditioner at least 3 times per week

Not cut their hair for the duration of the study

Not chemically treat (colour, perm, straighten, relax, etc.) for the duration of the study.

Exclusion Criteria

Exclusion Criteria

If female, is pregnant or lactating or planning to become pregnant during the study timing

Evidence of concomitant skin diseases of the scalp (psoriasis, psoriasiform eczema, lichenoid eruption, tinea capitis or other scalp infections or infestations)

History of psoriasis, atopic dermatitis, urticaria, chronic kidney disease, chronic liver disease, immunodeficiency disorders/conditions, haematological disorders or chronic pain disorders

Current or previous diagnosis of skin cancer (within past 5 years)

Evidence of significant scalp scarring that will interfere with evaluations

History of allergic reaction to shampoo, perfumes, or topically applied hair care products

Currently participating or has participated in an investigational drug study or hair care study in the 4 weeks prior to Enrolment

Has a condition or is using a medication that in the opinion of the investigator or their designee could jeopardize the safety of the subject, interfere with the evaluations, or confound the interpretation of the study results

Is an employee of the Clinical Site or Sponsor organization

Exclusion Criteria at Baseline

Has used anti-dandruff, anti-psoriatic, or anti-seborrheic dermatitis shampoos and/or treatment products within the 2 weeks prior to the Baseline visit

Has used any other shampoo products other than the provided shampoo during the 2 weeks prior to the Baseline visit

Expenses

you will receive a expenses of £90.00 if you complete the full study.

If you take part in the group for additional assessment you will receive an additional £10 expenses.

How to Apply

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

 

We are looking for volunteers age 18-65 to take part in our dandruff study starting week beginning Monday 25 March 2019.

If you suffer with dandruff and would be interested please email Recruitment@albavolunteers.com and we will send you out the full study information.