ArticlePDF Available

A randomized, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff

Authors:

Abstract and Figures

Ketoconazole is highly effective against the yeast Pityrosporum ovale, an organism believed to be involved in the pathogenesis of dandruff. Our purpose was to evaluate the safety and effectiveness of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo and placebo shampoo in patients with moderate to severe dandruff. Features assessed included adherent and loose dandruff scores, presence or absence of irritation, itching, yeast cells, and global improvement rating by the investigator. A total of 246 patients were included. Mean total adherent dandruff score declined throughout the treatment period with both ketoconazole 2% and selenium sulfide 2.5% shampoos significantly better than placebo at all visits. Ketoconazole was statistically superior to selenium sulfide at day 8 only (p = 0.0026). Both medicated shampoos were significantly better than placebo for reducing irritation and itching. Of the nine adverse experiences reported during the treatment phase, all involved patients treated with selenium sulfide 2.5% shampoo. Both ketoconazole 2% shampoo and selenium sulfide 2.5% shampoo are effective in the treatment of moderate to severe dandruff; however, ketoconazole 2% shampoo appears to be better tolerated.
Content may be subject to copyright.
A randomized, double-blind, placebo-controlled trial
of
ketoconazole
20/0
shampoo versus selenium sulfide
2.5% shampoo in the treatment of moderate to
severe dandruff
F.
William
Danby,
MD,
FRcpC,a
W.
Stuart
Maddin,
MD,
FRCPC,b
Lynette
J.
Margesson,
MD,
Fk.Cl'C,"
and
Donald
Rosenthal,
MD,
FRCPCc
Kingston and Hamilton, Ontario, and Vancouver, British Columbia, Canada
Background: Ketoconazole is highly effective against the yeast Pityrosporum ovale, an or-
ganism believed to be involved in the pathogenesis of dandruff.
Objective:
Our
purpose was to evaluate the safety and effectiveness of ketoconazole 2%
shampoo versus selenium sulfide 2.5% shampoo and placebo shampoo in patients with
mod-
erate
to severe dandruff.
Methods: Features assessedincludedadherent and loosedandruffscores, presence or absence
of irritation, itching, yeast cells, and global improvement rating by the investigator.
Results: A total of 246 patients were included. Mean total adherent dandruffscore declined
throughout the treatment period with both ketoconazole 2% and selenium sulfide 2.5%
shampoos significantly better
than
placebo at all visits. Ketoconazole was statistically supe-
rior to selenium sulfide
at
day 8 only (p = 0.0026). Both medicated shampoos were signif-
icantlybetter
than
placebo for reducingirritation and itching.
Of
the nineadverse experiences
reported during
the
treatmentphase, all involvedpatients treated with selenium sulfide 2.5%
shampoo.
Conclusion: Both ketoconazole 2% shampoo and selenium sulfide 2.5% shampoo
are
effec-
tive in
the
treatmentof moderate to severedandruff; however,ketoconazole 2%shampoo ap-
pears to be better tolerated.
(J
AM
ACAD
DERMATOL
1993;29:1008-12.)
Dandruff
is a
milder
form
of
seborrheic
dermati-
tis
and
the
yeast
Pityrosporum ovaleis involved
in
its
pathogenesis.
During
treatment,
P. ovale levels
are
reduced
or
eliminated;
on
disease
recurrence,
this
yeast
can
again
be
demonstrated.
1
Disease
hseverity
also
correlates
with
the
number
of
organ-
isms.?
Ketoconazole
is
highly
effective
against
P.
ovaler-"
Therefore
we
compared
the
efficacy of ke-
toconazole
2%
shampoo
versus
selenium
sulfide
From the Division of Dermatology, Queen's University, Kingston";
University of British Columbia, Vancouver''; and the Department of
Medicine, Division of Dermatology, McMaster University, Hamil-
ton."
Supported by Janssen Pharrnaceutica Inc.
Reprint requests: F. William Danby, MD, Queen's University, 190
Wellington St., Fourth Floor, Kingston, Ontario, Canada K7L 3E4.
Copyright @ 1993 by the American Academy of Dermatology, Inc.
0190-9622/93
$\.00+
.10
16/1/48764
1008
2.5%
shampoo
in
patients
with
moderate
to severe
dandruff.
METHODS
Male and female patients with moderate to severe
dandruff were eligible to enter this randomized, double-
blind, placebo-controlled study. Patients were stratified
bysexina 3:2male-to-femaleratio to simulatethe patient
distribution found in the general population of persons
with dandruff.
The
study consisted of three phases. The first was a
2-week washout period, during which patients sham-
pooed two times per week at home with a nonmedicated
shampoo.
At
the end of this period, a preliminary
dandruffassessment was performed.
If
the total adherent
dandruff score was higher than 14
out
of a possible 60,
patients were eligible to enter a 4-week, double-blind
treatment period during which they were randomized to
one of the following treatments: 2% ketoconazole sham-
poo, 2.5% selenium sulfide shampoo, or placebo (keto-
Journal of the American Academy of Dermatology
Volume 29, Number 6
Danby et al.
1009
30
25
5
Day 15
V
isit
D Y
o
~
~
-"':
:"-
,.£-.
,..-
_-:....
_ _
J...-
--:..J
Day 1 Day 8 Day 29
-13- 2 Ketoconazole
- 2.5% Selen
ium
Placebo
Fig. 1. Mean total
adherent
dandruff
severity
scores
at
each
visit.
conazole
shampoo
vehicle)
shampoo
in a
2:2:1
ratio,
respectively.
Those
patients
who
responded
during
the
double-blind
treatment
period
were
eligible
to enter a
3-week
follow-up
period
to
determine
relapse.
During the
double-blind
treatment
period,
patients
were
shampooed
twice
a
week
at the
study
facility
bya
technician.
Clinical
assessments
were
performed
3
days
after the
most
recent
shampooing
at day1andat
weeks
1,2, and4.
During
the
3-week
follow-up,
patients
sham-
pooed at
home
twice
weekly
with
the
non
medicated
shampoo and
were
assessed
weekly.
Patients
were
excluded
from
study
entry
if theyhad
psoriasis,
atopic
dermatitis, tinea
capitis,
Parkinson's
dis-
ease,
were
sensitive
or
allergic
to
shampoos/soaps,
im-
munodeficient,
taking
antibiotics
or
antimycotics,
or
pregnantor
lactating.
Adherent
and
loose
dandruff
scores
were
determined
by
visual
examination
of
six
scalp
areas
(0:=
none;
1-2 =
almost
none/very
slight;
3-4
=
mild;
5-6=
mod-
erate;
7-8:=
marked;
9-10:=
severe/heavy).
In
addition,
the
presence
or
absence
of
irritation
and
itching,
global
improvement
ratingas
assessed
bythe
investigator
(com-
pletely
cleared,
excellent,
good,
fair,
poor,
and
unevalu-
able)andthe
presence
ora
bsence
of
yeast
cells
as
detected
by oil
immersion
microscopy
were
examined.
RESULTS
A total of246patients wereincluded.
Of
these97,
100, and 49 patients were assigned to the ketocon-
azole, selenium sulfide, and placebo shampoos, re-
spectively.The
3:2sex ratio (141 men, 105women)
was closely approximated.
The three treatment groups did not differ statis-
tically with respect to sex distribution, age, racial
background, concomitant medications, disease du-
ration, and adherent dandruff severity score. Over-
all the mean age was
33.7 years (range 5 to 78
years),and duration ofdiseasewas 10.2 years (range
0.5 to 60 years). Approximately one third of all pa-
tients
had
seborrheic dermatitis.
Nosignificantdifferencesbetween the three treat-
ment groups were found with respect to any of the
baseline observations.
The primary efficacy variable, mean total adher-
ent dandruff score (Fig. 1) declined progressively
throughout thetreatmentperiodwith alltreatments.
However, at day 29, the reduction was much less
marked in the placebo group (44.5%;
n =49) than
in the ketoconazole (73.0%; n =94) and selenium
(66.7%;
n =95) groups.
Both of the medicated shampoos were signifi-
cantly better than placebo at all three visits.Keto-
conazole was significantly better than selenium at
day 8 only
(p =0.0026; adjusted alpha = 0.0056
pairedcomparison, LSMEANS). A similar pattern
was seen for the mean total loose dandruff scores;
however, the magnitude of
the
decreases was less.
Both medicated shampoos were significantly better
than placebo, but not significantly different from
each other.
At baseline, approximately one third of all pa-
tientsin each treatment group had irritation. At the
end of the treatment period it was found that both
medicated shampoosshowed increases, in the order
of 25% (ketoconazole
[n = 23]; selenium sulfide
[n =20D, in the total percentage of patients having
no irritation versus 8% (n =4) for placebo, which
washighlysignificant(X
2
,
p =<0.000 I) (Fig. 2). A
1010 Danby et al.
Journal of the American Academy of Dermatology
December 1993
100
60
40
20
o
Day
1
Day
8
70
_ 2%
Ketoconazole
~
2.5% Selenium 0
Placebo
Fig. 2. Absence of irritation at each visit.
Ketoconazole
2%
Selenium
Placebo
IZ2lResponders
~
Non-responders
Fig. 3. Treatment respondersversus nonrespondersat day 29.
similar analysisof
the
presence
or
absenceof itching
yielded a
45%
decrease (ketoconazole [n
==
45]; se-
lenium sulfide
[n
==
50]) in
the
presence of itching
for bothmedicated shampoos compared with a 20%
decrease
(n
==
10) in the placebo group.
When
the
global improvement ratings were
grouped into
the
categories of responders (ratings of
good, excellent, or cleared) and nonresponders (rat-
ings of poor or fair), a significant difference in per-
centage of responders was seen for both ketocona-
zole
(64.9%; p <0.001, adjusted pairwise compari-
son;
n
==
61)
and selenium (54.7%; p
==
0.004,
adjusted pairwise comparison;
n
==
52) compared
with placebo (28.6%;
n
==
14) (Fig. 3).
A comparison of the presence or absence of yeast
cells at the end of
the
treatment period compared
with baseline showed
that
ketoconazole and sele-
niumshampoosdecreased
the
percentageofpatients
with detectable yeast cells by
59.4% (n
==
57) and
48%
(n
==
48) (X
2
P <0.0001), respectively. These
are significant compared with
the
11.1%(n
==
7) in-
crease for placebo (Fig.
4).
Of
the
127 patients who qualified as treatment
responders on day 29, 103 entered the follow-up
phase,
53,44,
and 6 patients on ketoconazole, sele-
nium, and placebo shampoos, respectively. During
this period,
mean
total adherent dandruff scores in
all threegroups increased progressively from day 29
Journal of the American Academy of Dermatology
Volume 29,Number 6
100
Danby et al. 1011
80
60
40
20
o
2% Ketoconazole 2.5% Selenium
Placebo
l72I
Day 1 g Day
29
Fig. 4. Presence of yeast cells at each visit.
(end
of treatment) scores; however, the increase
appeared more rapid in the placebo-treated group,
although small numbers
(n =6) in the placebo
group make meaningful interpretation difficult. A
similarpattern wasseenfor the mean loosedandruff
score.
An
examination of the presence or absence of
irritation did not reveal any significant changes
from
day 29 to day 50 for either of the previously
medicated groups. However, the incidence of itch-
ing did increase by approximately
20% (ketocona-
zole [n
=9]; selenium sulfide [n = 8]) in the two
treated
groups. The number of patients (6) in the
placebo group was too small to detect a consistent
trend.
Between days
29 and 50there was an increase in
the
percentage of patients with yeast indicative of
relapse;
13.1
%(n =5) and
24.0%
(n =9) inthe ke-
toconazole- and selenium-treated groups, respec-
tively, and
41.6%
(n = 1) in the placebo group.
A total of 15 adverse experiences were reported
by 14 patients. Nine of these occurred during the
treatment phase, the remainder during the follow-
up period. All adverse experiences reported during
the
treatment phase involved patients treated with
selenium sulfide and included pruritus or burning
sensation on scalp (three), eruption near the hair
line (one), psoriasis (one), lightening/bleaching of
hair color (two), orange staining of the scalp
(one), and a chemical taste while being shampooed
(one).
A posttreatment questionnaire was administered
to assess patient rating of test shampoo. The per-
centage of patients rating their treatment as good,
verygood, or excellentwas
84.6%
and
73.6%for the
ketoconazole and selenium shampoos, respectively,
compared with
41.6%for
the
placebo.
DISCUSSION
The results of this study indicate
that
both keto-
conazole
2%
shampoo and selenium sulfide 2.5%
shampoo are effective antidandruff medications;
both were statistically superior to placebo in reduc-
ingadherentand
loose
dandrufflevels.This
confirms
the results of previousstudies comparing ketocona-
zole 2%shampoo versus placebo-6
and
versus sele-
nium sulfide,"
*Although there were no consistent
statistically significant differences between the two
medicated shampoos, all nine adverse experiences
reported during the treatment phase occurred with
selenium sulfide shampoo; thus ketoconazole
2%
shampoo may be better tolerated
than
selenium sul-
fide.
There was no measurable absorption of keto-
conazole, which agrees with the results of Van Lint
et
a1.
8
REFERENCES
I. Shuster S.The aetiologyof dandruff and the mode of ac-
tionof therapeuticagents.Br
J Dermato11984;
III
:235~42.
2. McGinleyKJ, LeydenJJ, Marples RR, et al. Quantitative
microbiology of the scalp
in non-dandruff, dandruff, and
seborrheicdermatitis. J Invest Dermatol 1975;64:401-5.
*Tanew
A, De
Doncker
P,
Schrooten
P. A
randomized
study
with
ke-
toconazole
2%
shampoo
or
2.5%
selenium
sulphide
shampoo
inthe
treatment
of
seborrhoeic
dermatitis
and/or
dandruff.
Satellite
Sym-
posium
to
the
2nd
International
Skin
Therapy
Symposium,
Antwerp,
Belgium,
May 5,1988.
1012 Danby et al.
3. Faergemann J. In vitro and in vivo activities of ketocona-
zole
and
itraconazole against P. orblculare. Antimicrob
Agents Chemother 1984;26:773-8.
4. Van Cutsem
J, Van Gerven F, Van Peer A, et a!' Ketocon-
azole:in vitroactivity againsl experimental pilyrosporosis in
guinea pigs and against dandruff in man. Bull Soc Fr My-
col
Med
1988;17:283-94.
5. Faergernann
J.
Treatment
of
seborrhoeic dermatitis of the
scalp with ketoconazole shampoo : a double-blind study.
Acta
Derm
Venereol (Stockh) 1990;70:171-2.
Journal
of the American
Ac
adem y of Dermatology
December 1993
6. Berger R, Mills
OH.
Double-blind, placebo-controlledtrial
of ketoconazole 2% shampoo in the treatment of moderate
to severe dandruff. Adv
Ther
1990;7:247-56.
7. BrownM, Evans TW, Poyner T, et al. The role
ofke
tocon-
azole 2% shampoo in the treatment and prophylactic mao-
agement of dandruff.
J Dermatol
Tre
at 1990;1:177-9.
8. Van Lint
J, De Doncker P, Woestenborghs R. Chronic use
of 2% ketoconazolc shampoo in patients with seborrheic
dermatitis and dandruff.
Curr
Ther
Res 1988;43:43-7.
BOUND
VOLUMES
AVAILABLE TO SUBSCRIBERS
Boundvolumesof the
JOURNAL
OF
THE
AMERICAN
AC
AD
EM
YOf D
ERM
AT
OLOGY
are availabletosubscribers (only) for the
1993
issues
fromthe Publisherat a cost of $69.00for domestic, $91.83for Canadian,and $87.00forinternational forvolume28 (January-June) and
vol
-
ume 29
(July-December), Shippingchargesare included.Each boundvolumecontains a subjectand author indexand all advertising isre-
moved.
Copies are shippedwithin 60 days after publicationof the lastissue inthe
volume.
The bindingisdurable buckram with the journal
name,volume number,and year stamped ingoldon the spine.
PaYl11
elll
I11I1St
accompany all orders.Contact Mosby-Year
Book,
Inc.,Sub-
scriptionServices, 11830Westline IndustrialDr., St. Louis,
MO
63146-3318
. USA: phone(800)
453-4351;
(314) 453-4351.
Subscriptions must be inforce to qualify. Bound volumes arenot availableinplace
oj
a regularjournal subscription.
... 24,26 Selenium disulfide shampoo (SeS 2 ) is another effective means in the treatment of dandruff, a milder form of seborrheic dermatitis. 27 SeS 2 has antifungal properties against Malassezia furfur and also inhibits Staphylococcus epidermidis growth in vitro. 23,28 Past reports on the treatment of scalp SD/D have focused on Malassezia spp and counts, while bacterial microbiota changes have only been poorly described. ...
... Both ketoconazole and SeS 2 are effective against dandruff and scalp SD. 27 However, little is yet known regarding their impact on the scalp microbiome in vivo. ...
Article
Full-text available
Objective Scalp seborrheic dermatitis (SD) is a chronic, relapsing, and inflammatory scalp disease. Studies indicate a global bacterial and fungal microbiota shift of scalp SD, as compared to healthy scalp. Ketoconazole and selenium disulfide (SeS2) improve clinical signs and symptoms in both scalp dandruff and SD. Aim The main objective of this study was to investigate the changes in the scalp microbiota diversity and counts in subjects with scalp SD during a two-phase treatment period. Material and methods The scalp microbiota and clinical efficacy were investigated in 68 subjects with mild-to-moderate scalp SD after an initial one-month treatment with 2% ketoconazole, and after a 2-month maintenance phase, either with a 1% SeS2-based shampoo or its vehicle. Results Thirty one subjects in the active and 37 subjects in the vehicle group participated. Ketoconazole provided an improvement of clinical symptoms (adherent (−1.75 p < 0.05), non-adherent (−1.5, p < 0.05)) flakes and erythema (scores 1.67–0.93, p < 0.001), in an increased fungal diversity and in a significant (p < 0.005) decrease of Malassezia spp. SeS2 provided an additional clinical improvement (−0.8; p = 0.0002 and −0.7; p = 0.0081 for adherent and non-adherent flakes, respectively, at Day 84) compared to the vehicle associated with a low Malassezia spp. count and an additional significant (p < 0.001) decrease of the Staphylococcus spp. level. Conclusion Selenium disulfide provides an additional benefit on the scalp microbiota and in clinical symptoms of SD and dandruff after treatment with ketoconazole. The results confirm the role of Staphylococcus spp. in scalp SD and open possible perspectives for preventing relapses.
... Dandruff is a skin condition that affects the scalp of up to half the world's population; this condition is characterized by an itchy, flaky scalp and is associated with various intrinsic and environmental factors, such as sebaceous secretions, skin surface fungal colonization, individual susceptibility [1][2][3]. Dandruff is believed to be a milder form of seborrheic dermatitis (SD), without visible inflammation and is limited to the scalp [4,5]. Despite having a high prevalence, the etiology of dandruff has not been fully elucidated. ...
Article
Full-text available
Abstract Background Dandruff is a chronic, recurring, and common scalp problem that is caused by several etiopathogeneses with complex mechanisms. Management of this condition is typically achieved via antifungal therapies. However, the precise roles played by microbiota in the development of the condition have not been elucidated. Despite their omnipresence on human scalp little is known about the co-occurrence/co-exclusion network of cutaneous microbiota. Results We characterized the scalp and hair surface bacterial and fungal communities of 95 dandruff-afflicted and healthy individuals residing in China. The degree distributions of co-occurrence/co-exclusion network in fungi-bacteria and bacteria-bacteria were higher in the healthy group (P
... Seborrheic dermatitis and Dandruff (D) are skin conditions found in sebaceous areas with hair. Dandruff is restricted to the scalp and involves itchy, flaking skin without visible inflammation, and is considered a mild non-inflammatory form of SD (Priestley and Savin, 1976;Danby et al., 1993;Warner et al., 2001). SD is a common chronic relapsing inflammatory skin disorder characterized by greasy scales with erythematous skin and exofoliative scaling (oily-yellow desquamation) on the scalp, which may extend to face, ears and upper chest associated with pruritus (Borda and Wikramanayake, 2015). ...
Article
Full-text available
The skin microbial community is a multifunctional ecosystem aiding prevention of infections from transient pathogens, maintenance of host immune homeostasis, and skin health. A better understanding of the complex milieu of microbe-microbe and host-microbe interactions will be required to define the ecosystem’s optimal function and enable rational design of microbiome targeted interventions. Malassezia, a fungal genus currently comprising 18 species and numerous functionally distinct strains, are lipid-dependent basidiomycetous yeasts and integral components of the skin microbiome. The high proportion of Malassezia in the skin microbiome makes understanding their role in healthy and diseased skin crucial to development of functional skin health knowledge and understanding of normal, healthy skin homeostasis. Over the last decade, new tools for Malassezia culture, detection, and genetic manipulation have revealed not only the ubiquity of Malassezia on skin but new pathogenic roles in seborrheic dermatitis, psoriasis, Crohn’s disease, and pancreatic ductal carcinoma. Application of these tools continues to peel back the layers of Malassezia/skin interactions, including clear examples of pathogenicity, commensalism, and potential protective or beneficial activities creating mutualism. Our increased understanding of host- and microbe-specific interactions should lead to identification of key factors that maintain skin in a state of healthy mutualism or, in turn, initiate pathogenic changes. These approaches are leading toward development of new therapeutic targets and treatment options. This review discusses recent developments that have expanded our understanding of Malassezia’s role in the skin microbiome, with a focus on its multiple roles in health and disease as commensal, pathogen, and protector.
Article
Seborrheic dermatitis is a common and chronic skin disease, which is particularly prevalent in older adults. While a specific cause of seborrheic dermatitis remains largely unelucidated, the currently understood pathogenesis of seborrheic dermatitis revolves around the presence of Malassezia yeast colonies and an inflammatory response in the affected individual. Keratinocyte proliferation resulting from inflammasome response in the host skin leads to the clinically relevant symptoms of seborrheic dermatitis. The increasing number of older adults as a percentage of the population in the USA will lead to an even higher prevalence of the disease in the ensuing decades. Fortunately, there are multiple treatment options based on individual patient situations and preferences. Topical treatment is the gold standard, but oral therapy may be required in certain cases. In order to maximize effectiveness and minimize adverse pharmacologic effects, effective treatment for older adults must take into account changes in lifestyle and metabolism that occur with aging.
Article
The authors provide a review of current concepts of the epidemiology, etiology, pathogenesis and treatment principles for seborrheic scalp dermatitis. They also describe the results of multiple national and foreign studies confirming high clinical efficacy of ketoconazole 2% shampoo in the therapy of seborrheic dermatitis.
Article
Pityriasis capitis simplex (Dandruff) is one of the most common scalp disorders with poor quality of life and pityriasic desquamation and pruritus on scalp. The main treatment options are antifungal agents and topical steroids. The aim of this study was to compare the clinical and symptomatic efficacy of strontium chloride hexahydrate 5% + licorice 1% combination (Storice®) with mometasone furoate 0.1%, a topical corticosteroid, in cases of pityriasis capitis simplex. 80 patients with a diagnodis of pityriasis capitis simplex were enrolled. 40 patients (20 males (50%), 20 females (50%)) were included in the mometasone furoate 0.1% group, and the remaining 40 patients (19 males (47.5%), 21 females (52.5%)) were included in the group of topical treatment agent (Storice®) consisting of strontium chloride hexahydrate 5% + licorice 1% combination. The clinical and symptomatic efficacy (pruritus and desquamation on scalp and life quality) of both agents were evaluated. Strontium chloride hexahydrate 5% + licorice 1% significantly reduces pruritus and improves quality of life by reducing clinical symptoms.
Chapter
Therapeutic shampoos are used around the world in both over-the-counter and prescription formulations because of their safety, efficacy, and ease of use for a variety of inflammatory scalp dermatoses including seborrheic dermatitis, psoriasis, and eczematous dermatoses, and as adjunctive treatment for tinea capitis. The majority of these products contain antifungal, anti-inflammatory, or keratolytic actions. Irritant and allergic contact dermatitis are the most common adverse effects of treatment.
Article
Ketoconazole is an imidazole antifungal agent with activity against a broad range of dermatophytes and yeasts including the yeast Pityrosporum ovale, which is thought to play an important role in the etiology of dandruff and seborrheic dermatitis. In order to confirm earlier reports of clinical effectiveness of ketoconazole in these conditions, a double-blind, placebo-controlled trial was conducted using a new 2% ketoconazole shampoo in volunteer subjects with active dandruff with or without accompanying seborrheic dermatitis. After a washout period using an unmedicated shampoo, 28 evaluable subjects were treated with ketoconazole 2% shampoo twice weekly while 24 subjects received a placebo shampoo. Subjects were treated for 1 month, with clinical assessments on days 15 and 29, after which responders were placed back on the unmediated shampoo and followed for up to 8 additional weeks to evaluate relapse. The clinical effect of ketoconazole was significantly (p<0.01) better than that of placebo for the principal efficacy parameter of adherent dandruff at both post-baseline assessment points. On day 29, 71% of those treated with ketoconazole but only 38% of those who received placebo demonstrated a ≥75% reduction in adherent dandruff. No adverse reactions occurred, and the ketoconazole formulation was well accepted by the patients. At the conclusion of the study, responders were placed back on a non-medicated commercial shampoo and reported times of relapse of dandruff symptoms, which was 15.1 days for ketoconazole versus 11.3 days for placebo.
Article
Thirty-three patients (18 males, 15 females) presenting with seborrheic dermatitis and dandruff washed their hair with a 2% ketoconazole shampoo, twice to three times weekly. Before entering the study and after a treatment duration of three to 26 months (mean, 16 months), plasma and blood were collected for the determination of ketoconazole concentrations and for liver function tests. Ketoconazole was not detectable in any of the plasma samples (detection limit, 2 ng/ml) and no abnormalities were seen in the liver function tests. It is concluded that the topical application of a 2% ketoconazole shampoo formulation does not produce any detectable plasma levels after chronic administration and that there is no risk of inducing abnormalities in liver function.
Article
A double-blind comparative study between ketoconazole 2% shampoo and selenium sulphide showed that both are effective in the treatment of dandruff, and that the ketoconazole shampoo reduces hair greasiness significantly and is the more acceptable formulation. In a double-blind placebo controlled study ketoconazole 2% shampoo used once weekly was found to be effective in preventing recurrence of dandruff in previously treated patients. © 1990 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
Article
The composition of the scalp microflora was assessed quantitatively in normal individuals and in patients with dandruff and seborrheic dermatitis, disorders characterized by increasing scalin. Three organisms were constantly found: (1) Pityrosporum, (2) aerobic cocci, and (3) Corynebacterium acnes. Pitrosporum (mainly Pityrosporum ovale) made up 46% of the total microflora in normals, 74% in dandruff, and 83% in seborrheic dermatitis. The geometric mean number of organisms per cm2 in non-dandruff subjects was 5.04 105; 9.22 105 in dandruff subjects; and 6.45 105 in those with seborrheic dermatitis. The cocci were dominantly Baird-Parkertype SII and no quantitative or qualitative change occurred in the scaling disorders. C. acnes comprised 26% of the flora on the normal scalp, 6% in dandruff, and only 1% in seborrheic dermatitis. These results differ significantly from previous reports which describe a much more complex microflora and suggest an etiologic role for microorganisms in dandruff.
Article
Thirty-six patients with seborrhoeic dermatitis of the scalp and culture positive for Pityrosporum ovale were treated in a double-blind placebo controlled study with ketoconazole shampoo twice weekly for 4 weeks. In the ketoconazole group, 16 of 18 patients (89%) became free of lesions or improved, compared with only 8 of 18 (p less than 0.01) in the placebo group. The patients found the shampoo effective, easy to use and cosmetically attractive.
Article
The MICs of ketoconazole and itraconazole against Pityrosporum orbiculare were 0.02 to 0.05 and 0.1 to 0.2 micrograms ml-1, respectively. In a rabbit model, orally administered ketoconazole (1 mg kg-1) afforded protection against experimental pityriasis (tinea) versicolor in all animals. Itraconazole (5 mg kg-1) was effective in four of five rabbits.
The aetiologyof dandruff and the mode of ac-tion of therapeuticagents
  • I Shuster
I. Shuster S. The aetiologyof dandruff and the mode of ac-tion of therapeuticagents. Br J Dermato11984;III :235~42.
A randomized study with ketoconazole 2% shampoo or 2.5% selenium sulphide shampoo in the treatment ofseborrhoeic dermatitis and/or dandruff
  • A Tanew
  • P Dedoncker
  • P Schrooten
*Tanew A, DeDoncker P, Schrooten P. A randomized study with ketoconazole 2% shampoo or 2.5% selenium sulphide shampoo in the treatment ofseborrhoeic dermatitis and/or dandruff. Satellite Symposium to the 2nd International SkinTherapy Symposium, Antwerp, Belgium, May 5,1988.
Ketoconazole: in vitro activity againsl experimental pilyrosporosis in guinea pigs and against dandruff in man
  • J Van Cutsem
  • F Van Gerven
  • A Van Peer
Van Cutsem J, Van Gerven F, Van Peer A, et a!' Ketoconazole: in vitro activity againsl experimental pilyrosporosis in guinea pigs and against dandruff in man. Bull Soc Fr Mycol Med 1988;17:283-94.