Transcript Ingen bildrubrik - Dr Irena Eris

[IPO0663] Study of the effects of cosmetic products to improve the condition of
dry skin
B.Tyszczuk1 , C. Vincent1 ,R. Debowska1 , A. Kaszuba2 , A. Kaszuba2 , I. Eris1
1
2
Dr. Irena Eris Cosmetic Laboratories, Dr. Irena Eris Centre for Science and Research, Warsaw, Poland
Specialist Medical Offices Dermed, Lodz, Poland
Introduction
Dry skin is nowadays a very common problem that may affect negatively the quality of life. It is perceived both as a skin care problem,
as well as one of the clinical elements in several dermatoses. The aim of this study was to evaluate the safety and efficacy of a dry
skin care program.
Materials and Methods
The study was performed in three phases:
TM
TM
Phase I: in vitro skin irritation test EpiDerm , patch tests in patients with allergy and assessment by a Safety Assessor. EpiDerm
was conducted according to the Standard Operation Protocol ECVAM (in vitro Skin Irritation Test: Human Skin Model, EpiDerm-200,
th
Version: 7.0, 30 Oct 2007). Shower gel assessment was conducted according to version: 5.0, Oct 2004.
Phase II: pre-clinical evaluation of tested cosmetic products (by 20 volunteers each) including objective analysis (skin condition
parameters evaluation- using equipment from Courage+Khazaka electronic GmbH) as well as self-evaluation questionnaire.
Phase III: clinical trial in two groups of 50 patients who used the same face care program (day and night creams) and different body
care programs (group A - shower gel and body lotion , group B - shower gel and body butter) for a period of 4 weeks. Dryness and
scaling of the skin was evaluated according to the 1 to 10 scale, where (1-2) - means slight increase in symptom, (3-5) - average
increase in symptom, (6-8) - strong increase in symptom and (9-10) - very strong increase in symptom. To assess the severity of
itching a 10- point visual analogue scale was used. Skin condition was assessed both by dermatologists and patients according to
questionnaires.
Safety assessment results (Phase I)
The in vitro skin irritation test results showed no irritation potential- cells
viability was above 80% for each tested product. According to protocol
cells viability should be higher than 50% to assess, that product as non
irritating.
Patch tests were conducted for each product on 30 patients with
allergies. Results of dermatological assessments confirmed safety of
tested products. Safety Assessor assessment confirmed that none of
tested formulations shows any foreseeable risk to human health under
conditions of normal use.
[IPO0663] Study of the effects of cosmetic products to improve the condition of
dry skin
sebum content [µg sebum/cm2]
80
75
70
65
60
55
50
before test after 30 min
night cream
after 2h
day cream
after 3h
body butter
after 4h
body lotion
Figure 1. Changes in skin moisturization after one use of
the product.
100
90
80
70
60
50
40
30
20
10
0
before test
night cream
after 30 min
day cream
after 2h
after 3h
body butter
after 4h
body lotion
Figure 2. Changes in sebum content after one use of the
product.
100%
100%
-38%
-24%
80%
TEWL [%]
moisturization [conventional units]
Results of pre-clinical evaluation (Phase II)
60%
40%
62%
76%
night cream
day cream
20%
0%
before test
Figure 3. Changes in transepidermal water loss after 2
weeks of treatment with day and night creme.
Preclinical test results showed significant improvement in
skin condition (figure 1-2). Afer one use of products both
moisturization and sebum content were maintaeined up
to 4 hours at a high level. Face care creams reduced
transepidermal water loss (TEWL) as well. Results
obtained after 2 weeks of treatment showed, that the
night cream had greater impact on the decrease in
TEWL (-38%), than the day cream (-24%) (figure 3).
[IPO0663] Study of the effects of cosmetic products to improve the condition of
dry skin
group A
decrease in skin
dryness (face):
decrease in skin
dryness (body):
decrease in scaling
(face):
-51% (for 98% of
volunteers)
-49% (for 100% of
volunteers)
-65%
(for 80% of
volunteers)
group B
-57% (for 98% of
volunteers)
-54% (for 100% of
volunteers)
-67% (for 62% of
volunteers)
itching of the skin (1 to 10 scale)
Results of clinical trial (Phase III)
5.0
4.0
4.7
- 50% (for 88% of
volunteers)
-60% (for 90% of
volunteers)
Figure 4. Dermatologist’s evaluation of products for dry skin.
Group A- day and night face creams, shower gel and body lotion.
4.8
-65%
3.0
2.0
1.0
2.3
-70%
1.7
1.7
0.7
0.0
face (group A +
group B)
body (group A)
before test
decrease in scaling
(body):
-64%
body (group B)
after 4 weeks
Figure 5. Volunteer’s self-evaluation of a decrease in skin itching.
Clinical trial results evaluated by dermatologists showed
reduction in skin dryness, itching and scaling (figure 4). Selfevaluation of volunteers in both preclinical and clinical trials
also confirmed very good influence of evaluated products on
their dry skin. Especially good results were observed for skin
itching decrease (figure 5).
Group B- day ang night face creams, shower gel and body butter.
Conclusions
The tested program for dry skin contains emollients, which are crucial for proper dry skin care and could be a very good suplement of
pharmacology treatments. Obtained results showed a significant impact of tested products on the dry skin condition (decrease in main
symptoms of dry skin e.g. scaling, itching), which was evaluated objectively and subjectively. Moreover such a treatment affects
positively the quality of life of people with the dry skin. This improvement was achieved by overcoming previous dryness, scaling and
itching of the skin.