213901

Spot Study

Study Summary

Alba Science would like to invite you to participate in a spot study using a facial lotion to assess the efficacy and tolerance of the facial lotion in reducing skin imperfections associated with acne/ spots under normal use conditions.  Efficacy and tolerance will be determined by expert assessment and consumer perception following 4 weeks of product use (twice daily applications).  Skin tolerance of the facial lotion will be evaluated according to the results of the objective and subjective data.

Approximately 100 female volunteers with oily spot prone skin will be recruited. 

The objective of the study is to evaluate the in-use efficacy and tolerance of the Facial Lotion on female subjects when applied to the face twice daily, for 4 weeks.  Skin evaluations will be performed by a Dermatology Consultant at Screening, Baseline, Week 1 and Week 4.  In addition, lesion counts will be repeated following a one-week and week 5.  Freshness effect will be evaluated immediately following the first application of the test material using a scale completed by the Subject under supervision from test personnel.  Consumer questionnaire will be completed immediately following the first application of the test material, and at the Week 1, Week 4 and Week 5 assessments.

On return to visit 2 if you are not suitable to carry on with the study you will receive £25 expenses,  if you complete all 5 visits you will receive £100 expenses.

Attendance – 5 Visits

You will be required to attend 5 visits in total to complete this study, 1 screening visit and 4 main study visits,  all visits will take approx. 1 hour and 30 minutes each.

Screening Visits (Please Choose from ONE of the visits below)

Tuesday 29 October 2019

This visit will take approx. 1 hour and 30 minutes.

Appointments will run between 9am – 4pm

Wednesday 30 October 2019

This visit will take approx. 1 hour and 30 minutes.

Appointments will run between 9am – 3:30pm

Thursday 31 October 2019

This visit will take approx. 1 hour and 30 minutes.

Appointments will run between 9am – 4pm

Friday 01 November 2019

This visit will take approx. 1 hour and 30 minutes.

Appointments will run between 9am – 4pm

Main Study

Group 1

Visit

Study Dates

Approx. Length of Study Visit

Appointment Times

Visit 2

Tuesday 12 November 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 3

Tuesday 19 November 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 4

Tuesday 10 December 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 5

Tuesday 17 December 2019

Approx. 1 Hour  & 30 Minutes

Appointments will run between 9am – 4pm

OR

Group 2

Visit

Study Dates

Approx. Length of Study Visit

Appointment Times

Visit 2

Friday 15 November 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 3

Friday 22 November 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 4

Friday 13 December 2019

Approx. 1 Hour & 30 Minutes

Appointments will run between 9am – 4pm

Visit 5

Friday 20 December 2019

Approx. 1 Hour  & 30 Minutes

Appointments will run between 9am – 4pm

Inclusion Criteria

Subjects Must Be:

Healthy Female.

Aged 18-40 years.

Must be Fitzpatrick skin types II – III.

Have oily skin (determined by Dermatology Consultant assessment).

Subjects presenting with visible imperfections on the face e.g. open pores, clogged pores, pimples, blackheads. Imperfections will be visualized by Dermascore device.

Subjects with at least 10 retentional lesions and 5 inflammatory lesions (pustules, papules).

Subjects presenting a dull complexion.

Subjects willing to use the facial lotion in place of their usual Facial Lotion.

Subjects are taking an effective oral contraception or other method of contraception.

Subjects are willing to refrain from using any cosmetic for oily skin/ regulation of sebum and acne for the duration of the study.

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

Provision of written informed consent to participate as shown by a witnessed signature on the Subject Consent Form.

Exclusion Criteria

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

Those who are pregnant or breastfeeding.

Those who are medications, including antibiotics, which in the opinion of the test personnel may affect the test results.

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

Those with an active skin disease or skin disorder (psoriasis, eczema, scars, wounds, active herpes or systemic infection) that could influence with the study evaluation or could require local or systemic therapy.

Those who have undergone surgical or non-surgical aesthetic procedures in the last 12 months (e.g. botox, fillers, chemical or mechanical peeling, dermabrasion, laser, pulsed light etc.)

Those who have received injections to the face for either medical or cosmetic purpose in the 6 months preceding to the start of the study.

Those who have taken an oral retinoid-based treatment in the last 6 months.

Those who have started, changed or discontinued hormonal treatment (combined oestrogen/progestin or cyproterone acetate) in the 3 months preceding to the start of the study.

Those who have received anti-acne and anti-seborrheic medical treatment (oral and topical) in the last 2 months.

Those who have used a topical retinoid treatment in the last 2 months.

Those who have performed facial aesthetic care at home or have received facial aesthetic care in a beauty salon (such as exfoliating scrub, mask) in the last month.

Those who have had an allergic reaction to a cosmetic product.

Those who have applied any products on their face (skin care or cleanser) or shampoo for 24 hours prior to the first product application at Visit 2.

Those who have used cosmetic products on assessment days (only water for cleansing face on the day of a test Centre visit).

  

Study Restrictions

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

Not to use aspirin, anti-inflammatory drugs, anti-histamines or corticosteroids for the duration of the study (paracetamol is permissible for pain relief). Subjects are requested to alert test personnel of any changes to medication during this study and are informed that certain medications may fall within the exclusion criteria, and may result in their withdrawal from the study.

Not to change your regular brands of other facial skincare products including cleansers and make up during the study.

To attend the test Centre visits having refrained from applying any products to your face.

To refrain from washing hair on the evening prior to and the morning of all test center visits.

Expenses

You will receive a cheque for £100 in your name on completion of this study.

How to Apply

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