2 Week Spot Study

Study Summary

Alba Science would like to invite you to participate in a 2 week spot study.  Skin inflammatory lesions or blemishes are disorders of the sebaceous gland.  Excessive sebum which is responsible for skin imperfections contribute to proliferation of bacteria Propionibacterium acnes (P. Acnes). This microorganism (P. Acnes) plays a role in the inflammatory phase of skin lesions/blemishes.

You are being asked to participate in a research study to evaluate a plasma home device.  The device will either be used on its own on incipient skin inflammatory lesions (spots), or in combination with a product and will be compared against the same cosmetic formula.  It is hoped that by combining the 2 treatments, the effects of these treatments on skin imperfections will be faster.

The duration of the study will be a maximum of 15 days for each person, including a wash-out period of at least 2 days.  The wash out period will be followed by a maximum of 10 days of treatment period but could be less.

Approximately 50-100 male/female volunteers, with oily or combination oily skin, with at least 2-4 skin inflammatory lesions on each side of the face, in the beginning phase (emerging spots) will be recruited.

You should not be taking any regular medication which may influence the response of the skin, e.g. anti-inflammatory medication, steroids or anti-histamines.

Attendance – 12 Visits

To be able to take part in this study you must attend all 12 visits.

Visit

Date

Approx. Length of Study Visit

Screening Visit

Thursday 05 October 2017

Approx. 90 minutes

Baseline Visit 1

Saturday 07 October 2017

Approx. 60 Minutes

Visit 2

Sunday 08 October 2017

Approx. 60 Minutes

Visit 3

Monday 09 October 2017

Approx. 60 Minutes

Visit 4

Tuesday 10 October 2017

Approx. 60 Minutes

Visit 5

Wednesday 11 October 2017

Approx. 60 Minutes

Visit 6

Thursday 12 October 2017

Approx. 60 Minutes

Visit 7

Friday 13 October 2017

Approx. 60 Minutes

Visit 8

Saturday 14 October 2017

Approx. 60 Minutes

Visit 9

Sunday 15 October 2017

Approx. 60 Minutes

Visit 10

Monday 16 October 2017

Approx. 60 Minutes

Visit 11

Tuesday 17 October 2017

Approx. 60 Minutes

Inclusion Criteria

Subjects must be:

Healthy Male or Female.

Aged 18-40 years.

Must be Fitzpatrick skin types I – IV.

Have an oily or combination oily skin with at least 2-4 emerging skin inflammatory lesions on each side of the face, with the exception of the nose and beard area (males).

Female subjects must be using an effective contraception and not have changed their contraception method in the previous 3 months or is planning to do so during the study.  If you are pregnant or think that you may be, or you are currently breast feeding, you must not take part in this study.

Willing to discontinue the use of any cosmetic products for oily or combination oily acne prone skin or anti-imperfections topical cosmetics during the entire study period.

Willing not to change your usual washing products and habits (e.g. shampoo, shower gel, eyes make up removers) throughout the course of the study.

Exclusion Criteria

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

Subject has medical diagnosis of acne vulgaris.

Women with irregular menstruation cycle.

Subject free of anti-acneic or anti-seborrheic topical cosmetic products for at least 15 days before the screening visit.

Subject free of anti-acneic or anti-seborrheic topical medical products for at least 1 month before the screening visit.

Subject with active skin condition (psoriasis, eczema, active herpes or systemic infection.

Subject having hairiness, moles, tattoos, scars, irritated skin etc. on the face.

Subjects who have used tanning beds within 4 weeks or have applied self-tanning products within 1 week.

Subjects who have changed their cosmetic washing habits for the area to be treated (Shower Gel, Shampoo) in the last 15 days before your baseline visit.

Subject who have changed their face skin care products in the past 15 days before screening.

Subjects who have had aesthetic care performed by a beautician (Deep Skin Cleansing) or underwent aesthetic acts performed by dermatologist (dermabrasion, peeling,  light-therapy, etc) on the face in the previous 3 months.

Subject receiving medical surgery or cosmetic surgery on the face within the last 6 months before baseline visits.

Subjects using any of the systemic or medical therapy mentioned in the table below:

Treatment name/type

Wash-out period

- Retinoids

*topic retinoid therapy

*oral retinoid therapy

2 months

6 months

- Fibrates and statines

1 month

- Cytoproterone acetate

3 months

- Chronic therapy with corticosteroids (inhaled administration is not considered as a systemic route) or thyroid extracts

3 months

- Chronic antibiotherapy (except penicillin) : topical or oral  

1 month

- Chronic NSAID (aspirin, ibuprofen,nurofen, naproxen, diclofenac) or anti-histaminic by general route

15 days

Subject who took short course treatment of corticosteroids,  antibiotics or anti-inflammatory drugs (oral or topical) within the last 7 days before you baseline visit.

Woman known to be pregnant, nursing or planning to become pregnant. 

Study Restrictions

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

  • Do not manipulate the lesions on your face (do not squeeze).
  • Do not change your cleansing habits (shampoo, bath/shower products, eye make-up removers).
  • Do not use any face skin care products (usual or new) except study products provided by Sponsor
  • Do not take a bath/shower/shampoo within 2 hours of your appointment time.
  • Do not undergo aesthetic care therapy (peeling, deep skin cleansing, light therapy, lasers, etc).
  • 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.
  • To refrain from having surgical or non-surgical aesthetic procedures during the study including Botox, fillers, lip enhancements, permanent or semi-permanent eyebrow or cosmetic treatments.
  • To refrain from exposing the facial skin to excessive natural sunlight or to other sources of UV light such as tanning beds.
  • Attend the test centre having refrained from applying any products to your face prior to each visit.

Expenses

You will be paid a £140 cheque in your name on completion of this study.

How to Apply

To take part in this study please email recruitment@albavolunteers.com or call 08007561046.