M
ea

n

Efficacy and tolerance of a new non-steroidal prescription 
cream in the treatment of mild facial seborrheic dermatitis.

Fall Clinical Dermatology Conference® October 12-15, 2017. Las Vegas, Nevada, USA

Valderas-Martinez P., Garre A., Granger C. 
Innovation & Development ISDIN S.A. Barcelona Spain

INTRODUCTION
Seborrheic dermatitis (SD) is a common, chronic, and 
relapsing dermatitis that is primarily patterned on 
sebum-rich parts of the face, retroauricular area, scalp, 
upper chest, and intertriginous areas  causing flaking, 
scaling, inflammation and pruritus with er ythema. 
Malassezia infection is an important pathogenic factor in 
SD. The density of this pathogen on the skin positively 
correlates with the severity of the disease. Topical 
antifungal treatments reduce malassezia proliferation and 
the resulting inflammation, leading to the improvement of 
SD. The aim of this study was to evaluate the efficacy and 
safety of a non-steroidal cream, containing zinc PCA, 
piroctone olamine, dihydroavenanthramide (SymCalmin), 
biosaccharide Gum-2 (Rhamnosoft), and stear yl 
glycyrrhetinate in the treatment of mild. 

METHODS
We evaluated the clinical efficacy of the new, non 
steroidal prescription cream on 33 patients diagnosed 
with mild facial seborrheic dermatitis who were treated 
for 28 days.Patients aged 18 years or older with SD on 
the face (IGA=2) were included in the study. Five centers 
participated in the study. The primary endpoint was to 
assess the efficacy using the Investigator Global 
Assessment (IGA) at day 28 ± 2 days as compared to 
baseline. Secondary objectives included: IGA after 10 
days of treatment, investigator assessment of symptoms 
(er ythema, itching, scaling, stinging), subjective 
evaluation  by patients of satisfaction of use, and quality 
of life using the SKINDEX-29 score. The IGA was rated 
using a 5-item score.

RESULTS  
Treatment proved successful in most patients (88%), and 
the IGA with a reduction of the IGA score at 28±2 days to 
0.66 ± 0.94 compared to IGA at 2 at baseline, SD was 
evaluated as absent in 56% of patients. After 10±2 days, 
treatment proved successful in most patients (79%), and 
the mean score of IGA at this visit was 1.00±0.75 (Figure 1).
On the baseline visit, 100% of the patients had erythema, 
this percentage decreased to 41% at final visit (Figure 2) 
with a mean intensity of erythema decreased from 1.18 ± 
0.39 at baseline to 0.47±0.62 (Figure 3). Regarding patients 
satisfaction and QoL, 78% of patients considered that the 
topical cream was good or excellent and the difference in 
total SKINDEX-29 score between visits (baseline and final 
visit) was reduced by 5.85±7.05 (Figure 4 and 5). None of 
the patients evaluated required rescue medication. There 
was 1 mild adverse reaction (erythema) during the study.  

ISDIN S.A.Provencals, 33 Barcelona Spain

IGA Score

M
ea

n

2,5

2

1,5

1

0,5

0
D0 D10 D28

Fi
g

u
re

 1

Fi
g

u
re

 3

Fi
g

u
re

 2

Fi
g

u
re

 4

Fi
g

u
re

 5
Improvement of the Erythema

M
ea

n

1,8
1,6
1,4
1,2

1
0,8
0,6
0,4
0,2

0

-0,4
-0,2

D0 D10 D28

Patient satisfaction

0,66±0,942±0IGA Score 1±0,75

SKINDEX-29: Quality of life score

M
ea

n

30

25

15

10

5

0

20

Functional 
dimension

Emotional 
dimension

Symptomatic 
dimension

D0 D28
Questionnaire: 0=very poor, 1=poor, 2=regular, 3=good, 4=excellent)

G
lo

ba
l r

at
in

g 
(m

ea
n)

Improvement of symptoms of DS

100

80

60

40

20

0
Erythema

67
,0

0%

The 
absorption 

of the 
product

The texture 
of the 

product

Tolerance The quickness 
of action of 

applied 
product

The 
effectiveness  
of the applied 

product

3,
34

3,
31

3,
09

3,
38

2,
94

40
,6

0%

10
0,

00
%

21
,0

0%

18
,8

0%

10
0,

00
%

30
,3

0%

18
,2

0%

78
,8

0%

21
,2

0%3
6,

40
%

36
,4

0%

Scaling Itching Stinging

D0 D28D10

CONCLUSIONS
The use of this new non-steroidal prescription cream 
t h a t c o n t a i n s z i n c P C A , p i ro c to n e o l a m i n e , 
dihydroavenanthramide, biosaccharide Gum-2, and 
stearyl glycyrrhetinate was shown to be effective in 
the treatment of mild facial seborrheic dermatitis. The 
product demonstrated a rapid efficacy profile after 10 
days of treatment and was well tolerated by the 
patients. The quality of life of the patients (Skindex-29) 
was improved. The product was well tolerated.


	FC17PosterISDINnonsteroidcreamValderas-Martinez.pdf