Clinical, Cosmetic and Investigational Dermatology
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Novel topical therapy for mild-to-moderate
This article was published in the following Dove Press journal: Clinical, Cosmetic and Investigational Dermatology15 September 2009Number of times this article has been viewed
Abstract: The benefits of vitamin D derivatives for the treatment of chronic plaque psoriasis
are well documented. Of importance is how compatible they are with, and how they compare to,
other established treatments for psoriasis. This paper reviews 15 studies with calcitriol 3 µg g-1
ointment (Silkis®/Vectical™ ointment; Galderma Laboratories) applied twice daily for up to
52 weeks. The ointment was found to be effective and safe for the treatment of mild-to-moderate plaque psoriasis including sensitive skin areas. Calcitriol 3 µg g-1 ointment was found to be as effective as, or even superior to, other established treatment modalities and more highly tolerated than other local treatment modalities in most studies’ comparisons. It could be combined with other psoriasis treatment modalities such as ultraviolet B phototherapy or topical corticosteroids in order to achieve a faster response and in order to reduce the risk of adverse events. Keywords: 1,25-dihydroxyvitamin D , calcitriol, psoriasis, therapy Introduction Psoriasis is a chronic inflammatory disease of the skin which affects about 2% to 3% of the population. About 15% to 20% of these patients suffer from additional inflammatory diseases of their joints. Some authors state that psoriatic arthritis is more common in severe and advanced cases of skin psoriasis, but in up to 15% of cases it precedes the skin disease and about 6% never develop skin lesions. Psoriasis of finger or toe nail involvement is also observed in many cases. The most frequent clinical form of the skin disease is plaque psoriasis with lesions preferentially located on the scalp, elbows, knees and the sacral area. Established topical treatments of plaque psoriasis include salicylic acid, corticosteroids, dithranol, tar, and both vitamin A and D derivatives. In cases recalcitrant to topical therapy or extensive or with palmoplantar skin area involvement additional ultraviolet phototherapy or, alternatively, systemic treatment modalities including methotrexate, retinoids, cyclosporine, fumarates and biologics could be administered.
The overall effectiveness of topical vitamin D derivatives in treating psoriasis is
well documented. Generally, patients show good tolerance to these agents, with no marked disturbance in their calcium metabolism,1,2 although hypercalcemia does occur
occasionally3,4 and some patients reported skin irritations5,6 The important consideration
for vitamin D derivatives now is their comparability and compatibility, both in terms
of effectiveness and tolerance, with other established treatments for psoriasis.
An ointment with 3 µg g-1 calcitriol (Silkis®/Vectical™ ointment; Galderma
Laboratories) was approved in Europe about 10 years ago and recently in the
US for the treatment of mild-to-moderate plaque psoriasis. This paper reviews a
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Clinical, Cosmetic and Investigational Dermatology 2009:2 153–159
2009 Kowalzick et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
number of studies in order to explore the characteristics
sensitizing, phototoxic or photoallergic potential of 3 µg g-1
of calcitriol and to establish its place in the armamen-
calcitriol ointment could be detected in animal and human
tarium available for the management of patients with
Pharmacology, mode of action, Clinical studies – general and pharmacokinetics methodology Several separate studies designed to asses the efficacy,
The role of calcitriol (1,25-dihydroxyvitamin D ), a naturally
tolerability, and safety of applying calcitriol 3 µg g-1 ointment
occurring endogenous hormonally-active derivative of
twice a day are reviewed here; two were comparisons
vitamin D, in keratinocyte proliferation and differentiation,
with an excipient, two were comparisons with other
together with its effects on the immune response, are the reasons
standard treatments for psoriasis, two were comparisons
for the interest in its potential to control hyperproliferative,
with calcipotriol, another vitamin D derivative, one was a
inflammatory skin diseases such as psoriasis. Receptors
comparison with tacrolimus, a drug not yet approved for
for calcitriol are found on epidermal keratinocytes and
psoriasis, four investigated the combination of calcitriol
dermal fibroblasts.7 Furthermore, keratinocyte growth and
with other therapies, and four were open, uncontrolled
differentiation are regulated by calcium concentration,8 and
investigations. Most of these studies have been reported in
as calcitriol increases intracellular calcium concentration,9
these processes may be indirectly affected by calcitriol.
All studies were conducted with adult patients of both
In vitro physiological studies have revealed that calcitriol
sexes with chronic plaque-type psoriasis. Unless otherwise
inhibits the proliferation of human skin cells and induces
specified, treatments were applied to all psoriatic lesions
them to differentiate into squamous and denucleated horny
(except the head) for the duration of the study or until the
cells.10,11 Additionally, calcitriol enhances the expression
lesions cleared up. Efficacy was mostly assessed in terms of
of keratins K10 and K6 in the keratinocyte population in
global improvement, with erythema, scaling, induration and
psoriasis plaques in vivo, which correlates with their clinical
pruritus being scored according to the scale of Fredriksson
improvement.12 Furthermore, it has been shown that calcitriol
and colleagues29 or global severity scores (GSS), physician’s
acts as an immunomodulator in the skin as a potent inhibitor
global assessment scores (PGA), and dermatological
of T-cell proliferation and of several inflammatory mediators
sum scores (DSS). In many studies the psoriasis area and
including interleukins-1, -6, and -8.13,14
severity index (PASI) score was used as a secondary efficacy
In preclinical and phase I to III studies it was demonstrated
variable.30 In studies directed to treatment of special sensitive
that 3 µg g-1 calcitriol ointment is the minimal optimal effective
skin areas modified PASI or target area scores (TAS) were
dose for treatment of psoriasis, had no systemic toxicity and
employed. Some studies included an evaluation of patients’
was tolerated well in the locality of application.15
quality of life during treatment using the psoriasis disability
In humans, following topical administration of 3 µg g-1 index (PDI) or quality of life (QOL) questionnaires about
calcitriol ointment to about 15% of the body surface area
for 12 hours, on average 7.5% of the calcitriol applied was
Evaluations were performed at the beginning of each
excreted mainly via feces over a 10-day period. The level of
study, at regular intervals throughout the relevant study, and at
serum calcitriol remained unchanged and traces of exogenous
the end of each study. Blood chemistry parameters, including
calcitriol were only detected in 25% of participants in the
serum albumin, total and adjusted calcium, urea, phosphate,
relevant study.15 The main concern about the use of vitamin D
alkaline phosphatase, and creatinine were also measured at
derivatives is their possible influence on calcium homeostasis.
In animals treated with 3 µg g-1 calcitriol ointment (on 15% of the body surface for four consecutive days) no increase in
Efficacy, safety, and patient
the urine calcium excretion could be observed as compared to animals treated with the excipient over 10 days.16 For health
acceptance
and safety reasons, in Europe, the use of 3 µg g-1 calcitriol Comparison with excipientointment is only approved for treatment of up to 35% of the
In two placebo-controlled multicenter randomized double-
body surface area in psoriasis patients with a maximum of
blind parallel group studies including 839 subjects, 3 µg g-1
30 g per day being the approved level in the US. No irritant,
calcitriol ointment or its excipient was administered twice
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Clinical, Cosmetic and Investigational Dermatology 2009:2
daily for up to eight weeks. In both studies the drug was
endpoint showed statistically signif icant (P 0.05)
shown to be significantly more effective (P = 0.005 and differences in favor of betamethasone dipropionate, P 0.001, respectively) according to the response rate, and
however the absolute reduction in mean PASI was
both according to GSS and DSS (P 0.01 to P 0.001,
comparable between the groups. A significantly (P 0.01)
respectively) in mild-to-moderate plaque psoriasis than its
higher proportion of patients who responded remained
excipient. Furthermore, itching was significantly reduced
in remission during the eight-week observation period
in the calcitriol-treated group in both studies (P 0.001).
following the calcitriol treatment (48%) as compared to
In both studies calcitriol ointment had no effect on calcium
the betamethasone treatment (25%). Seven patients in
homeostasis as well demonstrating a good systemic and
each treatment group reported local skin irritations. Two
local safety profile in comparison to the groups being treated
patients treated with calcitriol exhibited slight, transient
with the excipient. There was a higher occurrence of local
asymptomatic hypercalcemia, whereas this observation was
adverse events in the relevant locality where the excipient
made in three cases of the betamethasone treated group.
Patients’ overall opinion of both ointments was generally “good” or “acceptable” in 91% of the calcitriol and in 92%
Comparison with short-contact dithranol of the betamethasone group, respectively.22In an open, parallel-group study patients were randomized to eight weeks’ treatment with either calcitriol 3 µg g-1 ointment Comparison with calcipotriolapplied twice daily or dithranol cream applied once daily.
To compare the efficacy and safety of calcitriol 3 µg g-1
Dithranol cream had to be removed after 30 min by shower
ointment and calcipotriol 50 µg g-1 ointment both were
bath. Its concentration started at 0.25% for the first seven days,
applied twice a day for 12 weeks, a multicenter, randomized
and then increased to 0%, 1%, and 2% at seven-day intervals
investigator-blind parallel group study including 250 patients
according to local tolerance. The global improvement scores
with mild-to-moderate plaque type psoriasis was performed.
and PASI scores were very similar between the two treatments;
At endpoint the mean score of global improvement (0 = no
considerable or definite improvement, or total clearance of
change or worsening, 3 = cleared or almost cleared) rated by
lesions, was observed in 72% of 60 calcitriol-treated patients
the physician was 2.27 for calcitriol and 2.22 for calcipitriol;
and 70% of 54 dithranol-treated patients, respectively. At the
such differences being statistically insignificant. The same
end of the study the improvements measured against the
parameter scored by the patients was 2.12 for calcitriol and
start of the study in the PASI scores were 64% and 57%,
2.09 for calcipotriol; again showing statistically insignificant
respectively. In addition to standard assessments, the effect of
differences. Mild to moderate skin irritation was observed
psoriasis on the patients’ quality of life was measured using
in percent of the patients treated with calcitriol and in 11%
the PDI questionnaire about daily activities. Patients were
treated with calcipotriol. The mean worst score for the
also asked to assess the acceptability of the two medications
cutaneous safety assessment (0 = none, 4 = very severe) was
in terms of staining, smell, ease of spreading and irritation.
lower in the calcitriol group (0.1) compared to the calcipotriol
Patients in the calcitriol group experienced a significantly
group (0.3) according to the physician’s judgment. This
higher quality of life during the study period, than those in
difference was significant (P 0.005) in favor of a better
the dithranol group (P 0.05) as determined using the PDI
cutaneous safety profile for calcitriol. According to the
questionnaire. There was also a significant difference in favor
patients’ judgment, the mean worst score for the cutaneous
of calcitriol ointment in the rating of staining and irritation
discomfort was lower in the calcitriol group (0.2) compared
(P 0.01) and a higher proportion in the calcitriol group
to the calcipotriol group (0.4). This difference was significant
rated the overall acceptability of treatment as good (47%)
(P 0.05) in favor of a better acceptance for calcitriol.24
In another intra-individual, randomized, investigator-
blinded left-right comparison study including 75 patients
with symmetrical mild-to-moderate plaque psoriasis
In a randomized multicenter trial with 258 patients
affecting sensitive areas (face, hairline, retroauricular and
with chronic plaque psoriasis either calcitriol 3 µg g-1 flexural areas) calcitriol 3 µg g-1 ointment was compared ointment or the topical corticosteroid betamethasone
to calcipotriol 50 µg g-1 ointment both administered twice
dipropionate were administered twice daily for six weeks.
daily. Global assessment of improvements as compared to the
Global improvement and global severity scores at treatment
beginning of the study by the investigators was significantly
Clinical, Cosmetic and Investigational Dermatology 2009:2
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better for the calcitriol treated lesions and the subjects’
being significant (P 0.05) in all but one of the time points
global preference was in favor of calcitriol (both P 0.05).
starting from week 1. This clinical response was reflected
Perilesional erythema, edema and stinging or burning were
in a highly significant difference (P = 0.005) in the mean
statistically significantly (P 0.05 to 0.001) less severe with
percentage reduction in PASI score for patients treated with
calcitriol compared to calcipotriol. The patients’ evaluation of
calcitriol plus UVB (65%) compared with those receiving
local tolerability in this study was significantly (P 0.0001)
phototherapy alone (43%). By study endpoint considerable
in favor of calcitriol, whereas there was no patient preference
or definite improvement or clearance of lesions was seen in
regarding both treatments according to efficacy.25
45% of patients treated with calcitriol plus UVB and in 20% of those receiving UVB alone. The mean cumulative UVB
dose was 5,291 J cm-2 in the calcitriol and 8,668 J cm-2 in
To compare the efficacy of calcitriol 3 µg g-1 ointment and of
the excipient group, respectively. Thus, on average, a 34%
the calcineurin antagonist tacrolimus in a 300 µg g-1 ointment lower dose of UVB was administered to calcitriol-treated either given twice daily for six weeks, a double-blind parallel
patients than to those in the control group.
group study was performed including 50 patients with
In another open intra-individual half-side manner study,
chronic plaque psoriasis involving facial and genitofemoral
ten patients with symmetrical plaque psoriasis were treated
areas. At the end of the study significantly (P 0.05) more
on one arm with calcitriol 3 µg g-1 ointment twice daily
patients treated with tacrolimus (60%) achieved complete
and on the other arm with dithranol ointment once daily.
or almost complete clearance according physicians global
Additionally, these patients received narrow-band (311 nm)
assessment compared to calcitriol (33%). The same was true
UVB phototherapy five times a week for at least four weeks.
for a target area score which at the end of treatment decreased
Both treatment modalities notably reduced the modified
by 52% with calcitriol and 64% with tacrolimus, respectively.
PASI score equally effectively. Three patients preferred
After two weeks, both calcitriol (71%) and tacrolimus (48%)
calcitriol rather than dithranol and one patient vice versa
induced considerable rates (nonsignificant) of perilesional
when both quality of life and treatment acceptability were
erythema. After six weeks, calcitriol induced a statistically
significant (P 0.005) higher rate (58%) compared to tacrolimus (16%). Nonsignificant differences were found for
edema, stinging/burning, and hot sensations, which occurred
In a small, double-blind, randomized study patients applied
in very few cases. In regard to overall tolerance, both treat-
either the potent topical corticosteroid betamethasone
ments were judged as excellent by 92% of the patients.27
valerate 0.1% ointment in the morning and calcitriol 3 µg g-1 ointment in the evening (n = 9), or betamethasone
valerate ointment in both the morning and the evening
(n = 10). Treatment lasted for six weeks.33 The combination
The efficacy of calcitriol 3 µg g-1 ointment in combination therapy was at least as effective as betamethasone alone, with ultraviolet (UV) B phototherapy was compared with
as indicated by the three measures of efficacy that were
phototherapy alone in an eight-week study.19 The research
assessed. At study endpoint 78% of patients using calcitriol/
was a double-blind study done through the use of vehicle
betamethasone and 60% of those using betamethasone daily
ointment in the control group. Patients received three sessions
showed considerable improvement, or better, according to
per week of broad-band UVB phototherapy until endpoint;
the mean global improvement score. Likewise, the global
dosage followed a defined schedule depending on the patient’s
severity score at endpoint was 1 (slight) for 78% of the
skin type. The dose of UVB was reduced or interrupted as
combination group and 50% of the betamethasone group.
necessary in cases of local intolerance. Ointments were
Finally, the mean PASI score for patients in the calcitriol/
applied after irradiation or at least six hours beforehand. The
betamethasone group decreased over the course of the
treatment groups were comparable at the start of the study;
study by 81% compared to 75% for betamethasone-treated
the mean PASI scores of 17.4 for 49 patients in the calcitriol
patients. No statistical analyses were performed due to the
group and 16.6 for 53 patients in the control group were not
significantly different. Mean global improvement scores
In another two-phase parallel-group study including
increased throughout the study period, with the difference
125 patients with chronic plaque type psoriasis either
between treatments in favor of calcitriol plus UVB therapy
calcitriol 3 µg g-1 ointment or calcipotriol 50 µg g-1
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Clinical, Cosmetic and Investigational Dermatology 2009:2
ointment were administered in the morning and the topical
To assess the long-term efficacy and safety of calcitriol,
corticosteroid clobetasol in the evening for two weeks,
an open-label multicenter study of 324 patients with mild-to-
followed by monotherapy with either calcitriol or calcipotriol
moderate plaque psoriasis were included. They received
twice daily for another 10 weeks. At week 2 in both arms,
calcitriol 3 µg g-1 ointment twice a day for up to 52 weeks.
more than 50% of the patients showed at least a marked
233 of the patients completed 26 weeks and 136 completed
improvement of their psoriasis and at week 12, 79% in the
52 weeks of treatment. Efficacy was demonstrated over the
calcitriol and 88% in the calcipotriol group, respectively.
course of the treatment assessed with an investigator-rated
Least-square means analysis of the PASI indicated both
severity score. This evaluation demonstrated no or minimal
regimens to be equivalent. There were no differences between
psoriasis symptoms in 11% of the treated patients after
the groups with regards to cutaneous safety or to incidence
12 weeks, in 22% after 24 weeks, in 37% after 36 weeks,
and in 47% after 52 weeks. The psoriasis involved body surface area decreased from 16% at the beginning to 11%
at the endpoints of the study. Serious adverse effects were
In three separate studies, calcitriol 3 µg g-1 ointment was reported in eight patients, all cases probably unrelated to the used to treat moderate or severe lesions of chronic plaque
study medication (skin ulcer at distant site, joint disorder,
psoriasis localized in sensitive skin areas. In an open,
two cases of metorrhagia, heart failure, hospitalization due
five-center study, treatment was applied for eight weeks by
to arteriosclerosis, breast cancer, and an infection following
11 male and 20 female patients with a history of psoriasis
a dog bite). Ten patients showed transient hypercalcemia
lasting from one to 757 months (mean 198 months)
but none was clinically significant or led to discontinuation
involving the face, hairline, or retroauricular areas.34
of the treatment. Furthermore, no clinically significant other
A good response to treatment, in terms of improvement
laboratory test parameters occurred. The global assessment
in scaling, erythema, induration, and pruritus, was seen
of improvement was rated by the patients. After 26 weeks
by week 4 which continued through to week 8. The global
53% and after 52 weeks 64% of the patients reported at least
improvement score indicated that at study endpoint, 74%
a marked improvement of their psoriasis while 4% had dis-
of patients were classified as definitely improved, or better.
continued the treatment due to lack of efficacy and 3% due
Another group of patients (12 males, 8 females) applied
calcitriol 3 µg g-1 ointment for 6 weeks to psoriatic plaques on the face, hairline or retroauricular areas in a single-center
Conclusions: Place of calcitriol
study.17 The clinical outcome showed a similar pattern to the previous study, although a higher proportion of
in therapy of mild-to-moderate
patients experienced clearing of their lesions.17 One patient
psoriasis
discontinued therapy prematurely, after 33 days of twice-
Twice-daily calcitriol 3 µg g-1 ointment was demonstrated
daily applications, due to complete clearance of lesions.
to be an effective and safe treatment for mild-to-moderate
In these two studies the cosmetic acceptability of treatment
plaque psoriasis,20 including sensitive skin areas.17,26,34
was judged as good by the vast majority of patients; only
The same is true for long-term treatment during and up to
one patient considered the medication to be cosmetically
For chronic conditions such as psoriasis the availability
In another study 60 patients with mild-to-moderate
of a range of therapies allows treatment to be adapted to
plaque psoriasis involving sensitive areas were treated with
patients’ needs, clinical response, and tolerance. It is therefore
calcitriol 3 µg g-1 ointment twice a day for 12 weeks. The important to determine the comparability and compatibility clinical remission rate progressively increased throughout
of different treatments and thereby to establish their place in
therapy from 11.6% at week 4 to 63.3% at week 12. No
serious adverse events and clinically relevant changes of
Investigation of the efficacy of twice-daily calcitriol 3 µg g-1
calcium homeostasis were observed. Six patients withdrew
ointment shows it to be as effective as short contact dithranol,
after four weeks of treatment because of increasing pruritus.
a well-established treatment for chronic plaque psoriasis.35
Another 12 patients noted mild skin irritation or pruritus
However, due to the much lower frequency of skin irritation
which spontaneously disappeared in six patients during
and staining, calcitriol was associated with significantly
better overall patient acceptability than dithranol cream.
Clinical, Cosmetic and Investigational Dermatology 2009:2
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Topical betamethasone dipropinate, a corticosteroid, was
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