213899

6 Week Patch Test - Sensitive Skin

Study Summary

Alba Science is inviting you to take part in a 6 week patch test in which cosmetic products will be tested.  The purpose of the study is to establish if any of the test materials are capable of causing a skin allergy.

On Weeks 1 - 3 weeks there will be patches being applied on Mondays, Wednesdays, and Fridays for 3 consecutive weeks. You will be asked to wear each patch for 24h (removing each one the day after it has been applied). You will be asked to discard the patch and remove any test material residue with a damp tissue.

On Week 4 of the study you are required only to attend twice, for an assessment on the Monday & Wednesday.

On Week 5 no attendance is required, and no patches will be applied.

On the Monday of Week 6 of the study we will apply the patches containing the same products to the original test sites (upper, outer arms), and a new test site (the back).  You will keep the patches in place for 24 hours and then remove them. You will then be required to return to the Test Centre on Wednesday, Thursday, and Friday of Week 6 for skin assessments.

We recommend that you wear clothing which is suitable to allow test personnel access to your upper arms & back with ease, and which is also resistant to staining. Unfortunately, we are unable to compensate for damage to clothing. You will be asked to remove the patches approximately 1 hour before attending the test centre each day, ensuring the patches are worn for 23h.

The areas of body which have had the patches applied will be assessed for skin reactions (i.e. redness, dryness) by trained personnel at each visit. On the final assessment day (Friday of Week 6), a Dermatology Consultant will be present to assess the areas where the patches have been applied.

Attendance

You will be required to attend 14 visits to our Broughton Street test centre.  Each Visit Will take Approx. 45 mins. please indicate which time slot would be suitable.

Please Choose one of the groups below:

Group 1 - You can attend any time between 9:45am – 10:15am each visit.

Group 2 - You can attend any time between 10:30am – 11am each visit.

Group 3 - You can attend any time between 11:15am – 11:45am each visit.

 

Study Dates Are below.

Week 1 = Wednesday 31 July 2019, Friday 02 August 2019.

Week 2 = Monday 05 August 2019,  Wednesday 07 August 2019, Friday 09 August 2019.

Week 3 = Monday 12 August 2019, Wednesday 14 August 2019, Friday 16 August 2019.

Week 4 = Monday 19 August 2019, Wednesday 21 August 2019.

Week 5 = No visits.

Week 6 = Monday 02 September 2019, Wednesday 04 September 2019, Thursday 05 September 2019 and Friday 06 September 2019.

Inclusion Criteria

Inclusion Criteria

  • Age 18 and over
  • Male & Female
  • Sensitive Skin
  • In general good health
  • Able to read and understand and sign the informed consent agreement after being advised of the nature of the study.
  • Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study.
  • Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study.

Exclusion Criteria

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

  • If you have any current active skin condition or skin disease.
  • Those who have a history of Psoriasis, eczema (in adult life).
  • If you have a history of skin cancer.
  • If you have received treatment (chemotherapy, radiation, immune suppressant medication)  for any type of cancer within 6 months.
  • If you have had a mastectomy or axillary lymph nodes removed.
  • If you have an autoimmune or immune deficiency disease (e.g. lupus,  myositis,  crohns disease, autoimmune thyroid disease, autoimmune hepatitis, etc.
  • If you are currently taking immunosuppressant medication.
  • If you are diabetic
  • If you have asthma or any other chronic respiratory condition requiring daily medication.
  • If you are taking daily antihistamine or any systemic or topical anti-inflammatory medications (e.g. ibuprofen).
  • If you have been using topical medication with 2 weeks of the start of the study.
  • If you are currently receiving allergy injections.
  • If you have a known sensitivity or allergy relating to the products.
  • If you have known sensitivity or allergy to adhesives, surgical tapes, bandages etc.
  • If you have scars, moles, sunburn, tattoos, etc on the patch area.

Alba Science may with the concurrence with the sponsor, include additional criteria that determine eligibility.

Study Restrictions

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

No immunisations during the study.

  • Do not use aspirin, anti-inflammatory drugs,  anti-histamines or systemic corticoids for the duration of the study (paracetamol is permissible).
  • No not use self-tanning lotion or any skin products on the test sites.
  • Do not go swimming or soak test are in the bath.

Expenses

You will be paid a £130 cheque in your name on completion of this study.

How to Apply

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