ARTICLE
Auteur(s) : Gérard Lorette1,
Valérie Ermosilla2
1Hôpital Trousseau, Service de Dermatologie, 37044
Tours Cedex 01, France
2Institut de Recherche Pierre-Fabre, Parc technologique
du canal, 4, rue Marie Curie, BP 33132, 31521 Ramonville,
France
3France : Michèle Decuyper, MD; Yolaine
Farcet, MD; Marie-Laure Flechet, MD; Jean-Luc Haziza, MD; Mireille
Ruer-Mulard, MD; Jean-Paul Poirier, MD; Jean-Marc Durand, MD;
Marie-Hélène Garnier–Calas, MD; Marie-Christine Pouget, MD, Michel
Weiller, MD. Tunisia : Rafia Nouira, MD, phD; Nejib
Doss, MD, phD; Amel Ben Osman, MD, phD; Ridha Kamoun, MD, phD;
Insaf Mokthar, MD, phD
accepté le 14 Mai 2006
Seborrheic dermatitis is a common chronic dermatological disease,
which occurs in about 3-5% of the adult population [1, 2].
Malassezia yeasts, commonly found as part of the normal skin flora,
could be an important factor in this disease, as they have been
found in higher proportions in patients with seborrheic dermatitis
or dandruff, its milder form [3-7]. M Restricta and M globosa
species appeared to be the most frequently related [3, 8, 9] but
the predominance M Furfur, M Sympodialis and M Obtusa has also been
reported [4, 7]. Their causative role in seborrheic dermatitis is
supported by several studies, which demonstrated the therapeutic
efficacy of topical antifungals at improving clinical lesions and
delaying symptoms recurrence [10-14], particularly by reducing the
number of Malassezia yeasts [15-17].Treatments combining
keratolytic agents or topical corticosteroids and antifungals,
tested for the potential complementary effect of their compounds,
also proved their efficacy [13, 17, 18]. In the same way, a new
association of ciclopiroxolamine (CPO) and zinc pyrithione (ZP) has
been proposed on the basis of the specific properties of the two
compounds.CPO is a broad-spectrum antifungal that also possesses an
anti-inflammatory activity by inhibiting prostaglandin and
leukotriene synthesis [19, 20]. Its efficacy in the treatment of
seborrheic dermatitis and dandruff has been demonstrated in several
randomised controlled trials, particularly when it is used at 1%
[14, 21, 22] and 1.5% concentrations [12, 23] or in combination
[13].Concerning ZP, it is known to have both a non-specific
keratolytic and antifungal activities [24, 25] and is effective in
the treatment of seborrheic dermatitis and dandruff [26], mostly by
normalising the altered stratum corneum ultrastructure that is
observed in the scalp with dandruff [27].The association of 1.5%
CPO/1% ZP has been tested in vitro on 2 species of Malassezia (M
globosa and M restricta) and showed a synergistic inhibitory and
fungicidal effect, with a higher efficacy compared to 2%
ketoconazole (Panizzotti C, submitted for publication). A pilot
clinical study has also shown the efficacy of the CPO/ZP
association at reducing the extent and severity of the lesions in
11 patients suffering from seborrheic dermatitis.The aim of this
study was to confirm these preliminary results and to evaluate the
clinical efficacy of a 1-month treatment with 1.5% CPO/1% ZP
shampoo compared to a 2% ketoconazole foaming gel and to the non
anti-fungal CPO/ZP shampoo washing base, in a large population of
patients with moderate to severe scalp seborrheic dermatitis.
Patients and methods
Study design
This multicentre, controlled, single blinded, randomised clinical
study was designed to compare 3 parallel groups and was conducted
from January to July 2004, by 16 dermatologists, 11 located in
France and 5 in Tunisia. It was carried out according to the
ethical principles stated in the Declaration of Helsinki, in
conformity with local legal requirements in each country and after
approval of the study protocol by the independent Ethics Committee
of Tours in France.
Patient population
Inclusion criteria
Male or female patients of 18 years old and more, presenting a
clinically diagnosed scalp seborrheic dermatitis including scales,
erythema and pruritus and a total lesional score ≥ 36 as defined in
Squire et al. [13], were recruited by French and Tunisian
dermatologists. Before enrolment, each participant signed a written
informed consent form.
Exclusion criteria
Patients presenting a seborrheic dermatitis with a lesional score
< 36 or requiring an associated topical corticosteroid treatment
and patients known to be allergic to one of the test components,
were not included in the study.
Patients who required systemic antibiotics, antifungals or
corticosteroids or who had used topical corticosteroids or
retinoids, or antibiotics and antifungals by topical or oral route
within the week before inclusion, or those who had taken oral
corticosteroids or retinoids within respectively the 14 days and
the 3 months prior to study entry, were also ineligible.
In the same way, patients unable to cooperate or already
participating in another study, pregnant or breastfeeding women,
immunodeficient patients and patients with scalp dermatosis or
taking any treatment able to interfere with the evaluation of
seborrheic dermatitis, were excluded.
Treatments
The 3 products were prepared, packed, labelled and numbered
according to a computer-generated randomisation list established by
the sponsor-assigned biostatistician, in order to be randomly
allocated to 3 parallel groups of patients. Patients received a
numbered shampoo bottle according to their order of inclusion with
either the 1.5% CPO/1% ZP shampoo (Kelual DS™, Laboratoires Pierre
Fabre) or a 2% ketoconazole foaming gel (Ketoderm®,
Janssen Cilag Laboratory) or the non-antifungal CPO/ZP-shampoo
washing base (vehicle shampoo). As the 3 treatments had a different
aspect, the study was single blind: in order to keep the
investigators unaware of the treatment allocation, the 3 products
were packed in identical opaque 200-mL bottles.
At the inclusion visit, patients received 1 bottle of shampoo
with the instructions for use for a twice-a-week application during
28 days. They were instructed not to apply another substance on the
scalp within the 2 hours following the treatment and the day of the
visits. Patients were also required to report in their diary the
changes in frequency and way of administration and at the last
study visit, to return the used bottle to the investigator who had
to estimate the remaining quantity (full, partially used or empty).
Any treatment able to interfere with the study outcome evaluation,
such as permanent waves and colorations, shampoos not provided in
the study, systemic or topical treatments with antibiotics,
antifungals, corticosteroids or retinoids or any topical treatment
for seborrheic dermatitis was strictly forbidden during the whole
study.
Evaluation criteria
Main efficacy criterion
The main efficacy criterion was assessed by the determination of a
global lesional score at baseline (D0), day 7 (D7), day 14 (D14)
and day 28 (D28), 2 days after the last shampoo. The lesional score
ranging from 0 to 80, and was calculated taking into account the
area covered by the seborrheic dermatitis lesions and its severity,
as described by Squire et al. [13].
Secondary criteria
Clinical symptoms
Erythema and pruritus were graded by the investigator at D0, D7,
D14 and D28, using a scale from 0 (absent) to 3 (severe).
Global efficacy assessment by Investigators and patients
At the final visit (D28), the global efficacy of the treatment was
graded by the investigator with a global assessment of aggravation:
0, stagnation: 1, mild improvement: 2, marked improvement: 3 and
recovery: 4, and by the patient using a 5-point scale from 0 (not
satisfying at all) to 4 (very satisfying).
Quality of life
The effect of the treatment on patient’s quality of life was
assessed by two questionnaires filled by the patient at the
beginning (D0) and at the end of the study (D28). The first one was
the French standard version of the SF-12 validated questionnaire
[28], which is generally used to measure general health status. The
lower the score, the more quality of life is affected.
The second questionnaire specifically measures the quality of
life of patients suffering from skin diseases. It was adapted with
the author consent from the 10-item validated Dermatology Life
Quality Index (DLQI) questionnaire [29], to be specific for the
scalp simply by replacing the word “skin” by “scalp” in each
question. Each item was scored using a 4-point scale from 0 (not at
all) to 3 (very much). The overall score was calculated by summing
the scores corresponding to each item and ranged from 0 to 30, with
higher scores indicating poorer quality of life. If 1 item was
unanswered, it was scored 0. If more than 1 item was missing, the
DLQI was excluded from the analysis.
Local tolerance
Local tolerance was assessed at each post-baseline visit by the
investigator. In case of an adverse event, its duration, severity
and consequences were reported to the investigator and registered.
Serious adverse events had to be reported to the sponsor within the
2 days following notification by the investigator.
Statistical methods
The statistical analysis was performed using SAS software, release
8.2.
All quantitative criteria were calculated and expressed by
sample size, mean, standard error (SE), median and range
values, and qualitative criteria by percentage and frequency.
At baseline, the comparison between the 3 treatment groups was
assessed for the quantitative criteria using analysis of variance
when the distribution was normal and otherwise using
Kruskall-Wallis test. For the qualitative criteria, the
Chi2 test or the Fischer exact test was used
for a sample size < 5 and the Kruskall-Wallis test for more than
4 classes.
Within groups time-effect analysis was performed using analysis
of variance completed by the Student or Wilcoxon paired tests. For
qualitative variables, the MacNemar test was used on series of
differences. Between groups analysis was performed using analysis
of variance for normal distributions or otherwise using
Kruskall-Wallis test.
All statistical tests were two-sided and were performed at a
significance level of 0.05.
Results
The flow of participants is shown in ( figure 1 ). A total of 189
patients were included in the intention-to-treat (ITT) population.
According to the randomisation, 63 patients were treated by the
CPO/ZP shampoo, 66 by ketoconazole foaming gel and 60 by the
vehicle shampoo. Fourteen patients were excluded from per-protocol
(PP) analysis due to major protocol deviations.
As similar results were generally obtained for PP population,
results are given for ITT population when not specified.
Demographic data and baseline clinical characteristics
Demographic data and clinical characteristics of patients at
baseline are shown in table 1( Table 1
). The ITT population included 101 men and 88 women, aged on
average of 39.33 ± 1.02 years (range 19 to 78 years). Demographic
data were not statistically different between groups at inclusion
except the height of the patients, which was significantly smaller
in the vehicle shampoo group than in the other groups and the
gender, significantly different between groups.
Concerning the clinical criteria at inclusion, no significant
difference was observed between the 3 treatment groups in terms of
lesional score (p = 0.831), erythema (p = 0.775) and pruritus (p =
0.072) (table 2( Table 2 )).
Table 1 Demographic data of patients at baseline in the
ITT population
|
Demographic characteristics
|
Total ITT population
|
CPO/ZP shampoo group
|
Ketoconazole gel group
|
Vehicle shampoo group
|
P value
|
|
N = 189
|
N = 63
|
N = 66
|
N = 60
|
|
Gender
|
|
|
|
|
|
|
|
Male
|
n (%)
|
101 (53.44)
|
27 (42.86)
|
34 (51.52)
|
40 (66.67)
|
0.009
|
|
Female
|
n (%)
|
88 (46.56)
|
36 (57.14)
|
32 (48.48)
|
20 (33.33)
|
|
|
Age (years)
|
Mean ± SE
|
39.33 ± 1.02
|
37.19 ±1.67
|
41±1.81
|
39.47 ± 1.78
|
0.255
|
|
Median (range)
|
37 (19-78)
|
34 (19-76)
|
39 (19-78)
|
37 (19-72)
|
|
|
Weight (Kg)
|
Mean ± SE
|
71.79 ± 0.96
|
71.83 ±1.77
|
72.09 ± 1.63
|
71.42 ± 1.59
|
0.960
|
|
Median (range)
|
70 (40-105)
|
72 (47-105)
|
71.5 (40-105)
|
70 (48-102)
|
|
|
Height (Cm)
|
Mean ± SE
|
168.41 ± 0.63
|
167.22±1.10
|
167.26 ± 1.04
|
170.92 ± 1.06
|
0.023
|
|
Median (range)
|
169 (149-196)
|
167 (152-196)
|
169 (149-185)
|
171 (155-192)
|
|
Table 2 Clinical characteristics of patients at
baseline in the ITT population
|
Clinical Characteristics
|
CPO/ZP shampoo group
|
Ketoconazole gel group
|
Vehicle shampoo group
|
P value
|
|
N = 63
|
N = 66
|
N = 60
|
|
Lesional score
|
Mean ± SE
|
46.46 ± 1.26
|
46.11 ± 1.22
|
45.37 ± 1.36
|
0.831*
|
|
Median (range)
|
42 (36-80)
|
42 (36-72)
|
42 (36-80)
|
|
|
Erythema n (%)
|
Absent (score: 0)
|
6 (9.52)
|
5 (7.58)
|
4 (6.67)
|
0.775§
|
|
Mild (score: 1)
|
28 (44.44)
|
30 (45.45)
|
28 (46.67)
|
|
|
Moderate (score: 2)
|
24 (38.10)
|
26 (39.39)
|
23 (38.33)
|
|
|
Severe (score: 3)
|
5 (7.94)
|
5 (7.58)
|
5 (8.33)
|
|
|
Pruritus n (%)
|
Absent (score: 0)
|
0 (0.00)
|
2 (3.03)
|
1 (1.67)
|
0.072§
|
|
Mild (score: 1)
|
8 (12.70)
|
10 (15.15)
|
15 (25)
|
|
|
Moderate (score: 2)
|
28 (44.44)
|
27 (40.91)
|
24 (40)
|
|
|
Severe (score: 3)
|
27 (42.86)
|
27 (40.91)
|
20 (33.33)
|
|
Primary criterion assessment
In the 3 treatment groups, the mean lesional score highly
significantly improved from baseline to each post-baseline visit (p
< 0.0001) (table 3( Table 3 )). At
each visit, the 2 antifungal treatments, CPO/ZP shampoo and
ketoconazole gel, had the same reducing effect on the lesional
score without any significant difference between the two groups.
Compared to the vehicle shampoo, the decrease of the lesional score
was more important with the 2 antifungals, with a slight,
non-significant difference at D7 (p = 0.071), which became highly
significant at D14 (p < 0.0001). In contrast, no significant
difference was observed between the 3 groups at D28, with a
lesional score reduction from baseline of – 16.46 ± 1.71 with
CPO/ZP shampoo, –16.98 ± 1.51 with the ketoconazole gel and
– 17.77±1.73 with the vehicle shampoo (p = 0.857).
In the PP population analysis, the same results were globally
obtained but a statistically significant difference of lesional
score was achieved at D7, favouring the 2 antifungal treatments
compared to the vehicle shampoo (p = 0.046).
Table 3 Lesional score evolution from D0 to D28 by
group of treatment in the ITT population
|
Lesional score
|
CPO/ZP shampoo group
|
Ketoconazole gel group
|
Vehicle shampoo group
|
P value†
|
|
N = 63
|
N = 66
|
N = 60
|
|
D0
|
Mean ± SE
|
46.46 ± 1.26
|
46.11 ± 1.22
|
45.37 ± 1.36
|
0.831
|
|
Median (range)
|
42 (36-80)
|
42 (36-72)
|
42 (36-80)
|
|
|
D7
|
Mean ± SE
|
20.37 ± 1.79
|
19.00 ± 1.46
|
24.05 ± 1.89
|
0.071
|
|
Median (range)
|
18 (0-80)
|
16.00 (0-50)
|
23.00 (3-64)
|
|
|
Variation from baseline
|
– 26.10 ± 2.10
|
– 27.11 ± 1.71
|
– 21.32 ± 1.78
|
|
|
P value*
|
< 0.0001
|
< 0.0001
|
< 0.0001
|
|
|
D14
|
Mean ± SE
|
11.32 ± 1.6a
|
10.20 ± 1.56b
|
22.98 ± 2.27c
|
< 0.0001
|
|
Median (range)
|
6 (0-52)
|
6.00 (0-80)
|
24.50 (0-64)
|
|
|
Variation from baseline
|
– 35.14 ± 1.83a
|
– 35.91 ± 1.99b
|
– 22.38 ± 2.27c
|
|
|
P value§
|
< 0.0001
|
< 0.0001
|
< 0.0001
|
|
|
D28
|
Mean ± SE
|
30.00 ± 1.55
|
29.12 ± 1.54
|
27.60 ± 1.81
|
0.857
|
|
Median (range)
|
32 (4-64)
|
27.50 (4-64)
|
25.00 (2-56)
|
|
|
Variation from baseline
|
– 16.46 ± 1.71
|
– 16.98 ± 1.51
|
– 17.77 ± 1.73
|
|
|
P value*
|
< 0.0001
|
< 0.0001
|
< 0.0001
|
|
Secondary criteria assessment
Clinical symptoms
The evaluation of erythema and pruritus evolution during treatment
is shown in the figures 2 and 3, respectively.
Erythema
The 3 treatments markedly and highly significantly reduced erythema
from D7 and at each pos-baseline visit (p < 0.0001), producing
the greatest improvement at D14, which was followed by a slight
downturn at D28 although erythema score remained far below the
values observed at D0.
Comparison between the 2 antifungal treatment groups revealed
the same improvement at D7 and D14 without any significant
difference between the CPO/ZP and ketoconazole groups (p = 0.992
and p = 0.954 respectively), whereas a slight advantage for the
CPO/ZP shampoo was observed at D28, although the difference was not
statistically significant (p = 0.115). By contrast, the vehicle
shampoo was far less efficient than both antifungal treatments at
D7 and D14 except at D28, with a significant difference between the
vehicle shampoo and respectively the CPO/ZP shampoo and the
ketoconazole gel at D7 (p = 0.041 and p = 0.046) and D14 (p = 0.003
and p = 0.001) and no significant difference at D28 (p = 0.443 and
p = 0.478).
Pruritus
The same profile was observed for pruritus, which was sharply
improved from D7 by the 3 treatments all over the study (p <
0.0001), with a slight downturn at D28 for the CPO/ZP and
ketoconazole treatments. A better efficacy was observed at D7 for
the CPO/ZP shampoo, which induced a significantly more important
decrease of the pruritus than the ketoconazole gel and the vehicle
shampoo (p = 0.032 and p < 0.001 respectively), which induced
the same effect (p = 0.133). At D14, the ketoconazole gel was as
effective as the CPO/ZP shampoo (p = 0.365), both being more
efficient than the vehicle shampoo (p = 0.002 and p = 0.0001
respectively), whereas at D28, the 3 treatments had the same
effect.
Global efficacy
Global efficacy of the treatments assessed at D28 by the
investigator and the patient is reported in ( figure 4 ).
Investigator’s assessment
With respectively 71% and 80% of patients improved or recovered by
the CPO/ZP shampoo and the ketoconazole gel, the 2 antifungal
treatments had the same efficacy according to the investigator (p =
0.557) and were highly significantly more efficient than the
vehicle shampoo (p < 0.0001) in reducing or curing seborrheic
dermatitis and its symptoms.
Patient’s assessment
The same pattern is observed for the patients’ evaluation,
respectively 73% and 80% of the patients treated by the CPO/ZP and
ketoconazole shampoos considered they were ’satisfied’ and ’very
satisfied’, compared to 42% of the patients treated with the
vehicle shampoo (p < 0.0002).
Tolerance
The CPO/ZP, ketoconazole, and vehicle shampoos were equally well
tolerated, with respectively 96.7%, 98.4% and 94.9% of the patients
having well and very well tolerated their treatment, without any
significant difference between the 3 products (p = 0.360).
Mild and moderate adverse events were experienced in 12
patients, 5 in the CPO/ZP shampoo group, 3 in the ketoconazole gel
group and 4 in the vehicle shampoo group. The most common were
scalp and face erythema, burning sensation, which were possibly
treatment-related but did not required any treatment
discontinuation and spontaneously resolved in half of cases.
Quality of life
Only the patients presenting available scores at inclusion and D28
were taken into consideration for the quality of life statistical
analysis. Thus, 140 patients were analysed in terms of general
health status (SF-12 questionnaire) and 169 for the scalp status
(adapted DLQI questionnaire).
Regarding the SF-12 score analysis, 47 patients treated by
CPO/ZP shampoo, 49 by ketoconazole gel and 44 by the vehicle
shampoo, were included. Scores were comparable at inclusion
concerning the mental and physical components (p = 0.979 and p =
0.354, respectively). Comparing the evolution between D0 and D28,
none of the 3 products demonstrated a significant improvement
neither on the mental or physical dimension. Moreover the
comparison between the 3 products in terms of mean evolution of
physical and mental scores (PCS-12 and MCS-12) did not show any
significant difference (p = 0.238 and p = 0.780 respectively).
As concerns the DLQI scores analysis (table 4( Table 4 )), it included 57 patients in the CPO/ZP
shampoo group, 58 in the ketoconazole gel group and 54 in the
vehicle shampoo group. DLQI scores were comparable at inclusion. At
D28, the 3 treatments significantly improved the DLQI scores, but
this improvement was higher for the CPO/ZP shampoo and the
ketoconazole gel than for the vehicle shampoo, with a mean increase
of the DLQI mean total score of 4.68 and 3.72 points respectively
versus 2.07 points (p < 0.05 in both cases).
An analysis of the DLQI by dimension was also performed. Only
the CPO/ZP shampoo induced a significant improvement from baseline
for the 6 dimensions (p < 0.05 in all cases). The “work” and
“treatment” dimensions as well as the “leisure” and “treatment”
dimensions were not significantly improved by respectively the
ketoconazole gel (p = 0.051 and p = 1.00) and the vehicle shampoo
(p = 0.067 and p = 0.766) treatments.
Table 4 Evolution of total DLQI score by treatment
group in the ITT population
|
Total DLQI score
|
CPO/ZP shampoo group
|
Ketoconazole gel group
|
Vehicle shampoo group
|
p-value†
|
|
n = 57
|
n = 58
|
n = 54
|
|
D0
|
Mean ± SE
|
5.98 ± 3.68
|
5 ± 3.18
|
4.74 ± 3.26
|
0.125
|
|
Median (Range)
|
5 (0–15)
|
4.50 (0–14)
|
4.50 (0–14)
|
|
D28
|
Mean ± SE
|
1.29 ± 1.83
|
1.27 ± 1.77
|
2.66 ± 2.44
|
|
|
Median (Range)
|
1 (0-7)
|
1 (0-8)
|
2 (0-10)
|
|
Mean change
|
Mean ± SE
|
-4.68 ± 3.64
|
-3.72 ± 3.59
|
-2.07 ± 3.16
|
0.0005
|
|
Median (Range)
|
-4 (-13–7)
|
-3.50 (-13–4)
|
-2 (-11–8)
|
|
P value§
|
< 0.0001
|
< 0.0001
|
< 0.0001
|
|
Discussion
This randomised single blind clinical study clearly demonstrated
the efficacy of the 1.5% CPO/1%ZP shampoo in the treatment of scalp
seborrheic dermatitis. From 1 week of treatment and all over the
treatment period, CPO/ZP shampoo highly significantly reduced the
extent and severity of scaling measured by the lesional score, as
well as erythema and pruritus related to the disease.
Between group analysis showed that CPO/ZP and ketoconazole
shampoos were more effective than the vehicle shampoo at D7 and
D14, both antifungal treatments producing with time a more and more
significant gain of efficacy. The effect of the vehicle shampoo,
which has also been observed in other clinical studies [12, 14, 30,
31], though significant, was much lower than that of the 2 other
products at D7 and D14.
Furthermore, CPO/ZP shampoo has a comparable efficacy as
ketoconazole foaming gel, as no significant difference was observed
between the two shampoos in terms of lesional score improvement and
reduction of erythema at all evaluation visits. However, it is
noteworthy that concerning pruritus, CPO/ZP shampoo seems to act
more rapidly and more efficiently than ketoconazole gel, by
producing at D7 a significantly greater decrease of pruritus, which
is often the first complaint of the patients. This fast and marked
effect can be due to the CPO component of the shampoo, which has
demonstrated its better efficacy in reducing overall scalp itching
in another study [13]. However, its superiority over ketoconazole
on this criterion remains to confirm, as it was not observed in all
the studies [12, 32].
The efficacy of the 3 treatments, though still highly
significant, slightly decreased with time at the end of the study.
Indeed, at the D28 visit, an increase of the lesional score was
observed in the 3 groups of treatment without any significant
difference between groups, indicating a slight general relapse of
the disease in the study population. While in the vehicle shampoo
group, the improvement of erythema and pruritus was quite similar
at D14 and D28, in the CPO/ZP and ketoconazole treated groups, it
decreased at D28 to reach the level achieved with the vehicle
shampoo.
These results are not in agreement with other comparative
studies evaluating the efficacy of ketoconazole [12, 30, 31, 33],
or CPO alone [21-23] or in association [13]. In all these studies,
ketoconazole foaming gel and CPO exerted a sustained marked effect
on seborrheic dermatitis all over the 4-week study duration, which
was maintained when relapse was evaluated during a follow-up period
after discontinuation of the treatment [12, 33].
Lack of adherence at the end of the study could explain these
conflicting results. With the marked and rapid improvement provided
by both antifungal shampoos after the 2 first weeks of treatment,
many patients could think that it was not necessary to follow the
treatment up to the end of the study and were less compliant.
Furthermore, though the lesional scores were rising again at D28,
they were still significantly lower than baseline values. Besides,
both investigators and patients assessed the global efficacy of the
products at D28 and found that the 2 active shampoos were highly
significantly more efficient than the vehicle shampoo, about 75% of
patients judging that their CPO/ZP or ketoconazole treatment was
“satisfying” and “very satisfying”.
Taking into account the complementary fungicidal and fungistatic
properties of CPO and ZP observed in in vitro studies and the
demonstrated clinical efficacy of the CPO/ZP combination in a
shampoo for the treatment of moderate to severe seborrheic
dermatitis, further studies on longer period of time are needed to
evaluate the remanence of its effects after treatment
discontinuation.
Acknowledgments: We thank Eric Myon for the analysis of
the quality of life questionnaires, Christophe Lauze for
statistical analyses and Marielle Romet for her contribution to the
elaboration of this manuscript.
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