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Efficacy and Safety of Tarcrolimus Cream 0.1% in The Treatment of Vitiligo
Efficacy and Safety of Tarcrolimus Cream 0.1% in The Treatment of Vitiligo
XXX
Blackwell
Oxford,
International
IJD
1365-4632
0011-9059
2008 The
UK
Publishing
International
Journal Ltd
of Dermatology
Society of Dermatology
Ai-E. Xu, BS, Di-Min Zhang, MM, Xiao-Dong Wei, BS, Bo Huang, MM, and Liang-Jun Lu, MM
Abstract
Background Vitiligo is an acquired, pigmentary skin disorder which is disfiguring and difficult
to treat. Phototherapy and application of topical corticosteroids are most commonly prescribed.
However, these therapies are often not effective and use of corticosteroids on the face may lead
to cutaneous atrophy, telangiectasia, and ocular complications.
Objective We sought to assess the efficacy of topical tacrolimus ointment in the treatment
of vitiligo.
Methods A prospective pilot study was performed of 30 patients with vitiligo. Patients were
treated with tacrolimus ointment for at least 4 months. Clinical responses were documented
during clinic visits, and by pretacrolimus and post-tacrolimus photography.
Results Twenty-five (83.3%) patients showed some repigmentation at the end of 4 months.
Patients with vitiligo for more than 5 years also responded well to tacrolimus ointment.
Repigmentation in active vitiligo was superior to that in stable vitiligo. 80% of patients with
segmental vitiligo of the head and neck showed some response to tacrolimus, but there was
no statistical significance between segmental and vulgaris vitiligo. The mean percentage of
repigmentation on the head and neck was greater than that on the trunk and extremities.
Four patients initially experienced burning on application.
Conclusions Topical tacrolimus ointment is an effective and well-tolerated alternative therapy
for vitiligo especially involving the head and neck.
Introduction
86
Vitiligo is an acquired pigmentary skin disorder with an estimated incidence of about 1% of world population affecting
both sexes equally.1,2 It is a disfiguring disease causing great
psychosocial stress and is characterized clinically by the development of depigmented macules and patches that correspond
histologically to decreased or absent cutaneous melanocytes.
The main mechanism of melanocyte destruction in vitiligo
is theorized to be an autoimmune lymphocytic attack on
melanocytes.1
Current treatment options aiming at repigmentation include
the application of potent topical corticosteroids and the administration of phototherapy, either psoralen-UVA (PUVA) or,
more recently, narrowband UVB.35 Although as many as
64% patients respond at least partially to the application of
medium-strength to potent topical corticosteroids,6 the risk of
cutaneous atrophy and telangiectasia, especially on the face
and in intertriginous areas, and of ocular adverse events when
applied to periorbital sites, precludes the prolonged use of
topical corticosteroids. Besides the problem of compliance for
regular hospital visits, narrow-band UVB treatment requires
expensive equipment and trained personnel, and PUVA is
International Journal of Dermatology 2009, 48, 8690
associated with a risk for cancer induction. So, the search for
newer therapeutic modalities continues.
Recently, successful treatment of vitiligo with the topical
calcineurin inhibitors tacrolimus ointment 0.1% and 0.03%
(Protopic) or pimecrolimus cream 1% (Elidel) has been
reported.79 Calcineurin-inhibitors act on T cells and mast cells,
inhibiting T-cell activation and production of cytokines and
preventing the release of pro-inflammatory mediators in mast
cells by degranulation.10 Tacrolimus ointment does not cause
the atrophy, telangiectasia, or adverse potential ocular effects
of topical corticosteroids and limited application to the face and
intertriginous areas.11 The present study was conducted in order
to assess the effect of tacrolimus ointment in treating vitiligo.
Materials and Methods
Study design
This was a prospective pilot study of response to treatment with
tacrolimus ointment of vitiligo in 30 patients conducted in 2005
and 2006.
Information collected in the routine clinical history included
patient sex, location and distribution of the disease, percentage of
depigmentation, age at onset, family history, and disease activity.
2009 The International Society of Dermatology
Xu et al.
Statistical analysis
Statistical analyses were performed using the analysis of
variance function and paired Student t-test with software.
Results
The mean age of the 30 patients was 22.3 7.8 years (range
740 years). There were 9 males and 21 females, and 25 of
them were less than 30 years old. The majority of patients
(80%) had vitiligo vulgaris, and 20% showed segmental
involvement. The mean duration of vitiligo before the initiation of therapy was 4 years (range: 0.2514 years). There were
7 patients with active vitiligo and 23 patients with stable
vitiligo. None of the patients had any associated autoimmune
disease and no one had previously repigmented spontaneously.
2009 The International Society of Dermatology
87
88
Xu et al.
Cheek
(n = 10)
Forehead
(n = 7)
Eyebrow
(n = 2)
Eyelid
(n = 5)
Prenarse
(n = 3)
Perioral
(n = 3)
Neck
(n = 5)
Trunk
(n = 4)
Hand
(n = 1)
0
125
2650
5175
76100
1
1
2
2
4
0
0
2
2
3
1
0
0
0
1
0
0
2
1
2
0
1
1
0
1
0
0
2
0
1
0
1
3
0
1
3
1
0
0
0
1
0
0
0
0
Progressive
phase (n = 7)
Stable phase
(n = 23)
0
125
2650
5175
76100
0
1
2
1
3
5
5
5
5
3
Xu et al.
89
90
Xu et al.
10
11
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