Guideline for the Diagnosis and Management of Vitiligo

D.J. Gawkrodger; A.D. Ormerod; L. Shaw; I. Mauri-Sole; M.E. Whitton; M.J. Watts; A.V. Anstey; J. Ingham; K. Young

The British Journal of Dermatology. 2008;159(5):1051-1076.

In All Patients With Vitiligo, What is the Efficacy of Applying Calcipotriol or Tacalcitol vs. Placebo or an Active Treatment in Terms of Condition Progression, Area Reduction and Quality of Life Score?

Introduction

The vitamin D analogues, calcipotriol and tacalcitol, may have a place in the treatment of vitiligo.

Methods

Nine papers met the criteria for inclusion as used for topical corticosteroids. In all trials but one (Chiaverini etal.,^[39] in which localized forms of vitiligo were included), only patients with generalized (symmetrical) types of vitiligo were studied.

Evidence Statements

The best study of calcipotriol is the randomized open left-vs.-right study of Chiaverini etal.,^[39] in which the effect over a 3-6-month period of the once daily application of calcipotriol is compared in symmetrical target lesions in 24 patients (15 females, nine males; age range 5-59years) with localized and generalized vitiligo. No repigmentation was noted in 21 of 23 patients after 3-6months. One patient had 5% repigmentation with calcipotriol; two had repigmentation with and without calcipotriol (P>0·5). An unpublished clinical trial of the efficacy of topical calcipotriol vs. vehicle for vitiligo showed no beneficial effect for the calcipotriol over the vehicle placebo (A. Bibby, LEO Pharma A/S, personal communication, 2008).

A study of topical betamethasone vs. calcipotriol vs. a combination of the two over 5-10weeks in 15, 16 and 18 adults, respectively, showed >50% repigmentation in two, one and four each out of 15 evaluable cases.^[37] The conclusion was that the results favoured the combination of topical betamethasone and calcipotriol over betamethasone alone. However, the numbers here are too small for a definitive conclusion and there has been no other study of this sort. An open study of twice daily topical calcipotriol (with PUVA in four patients) in 26 patients (16 females, 10 males; age range 5-61years; 22 Asians) for 3-9months showed that 17 of 22 receiving monotherapy with calcipotriol had 30-100% repigmentation which was >50% in 12.^[40]

There have been studies of the effect of combining topical calcipotriol with phototherapy (see below).^{[19,41,42,43,44]}

Evidence to Recommendations

For generalized symmetrical or localized types of vitiligo, topical calcipotriol by itself has no effect in vitiligo and is not recommended. For generalized symmetrical types of vitiligo, the addition of topical calcipotriol to narrowband (NB) UVB does not add any benefit and is not recommended. The use of topical calcipotriol with PUVA may produce earlier repigmentation but it is not clear whether the final degree of repigmentation is enhanced. There is insufficient evidence to make a comment about the use of tacalcitol.

Recommendation

The use of topical calcipotriol as a monotherapy is not recommended.

Grade of recommendation B

Level of evidence 2++

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Next Section

References

Table 1 Levels of Evidence (from Scottish Inter-Collegiate Guidelines Network)
	Levels of evidence
1++	High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+	Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-	Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++	High-quality systematic reviews of case-control or cohort studies High-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal
2+	Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal
2-	Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal
3	Nonanalytical studies, e.g. case reports, case series
4	Expert opinion

RCT = randomized controlled trial.

Table 2. Grades of Recommendation (from Scottish Inter-Collegiate Guidelines Network)
	Grades of recommendation
A	At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B	A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+
C	A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

RCT = randomized controlled

Table 1 Levels of Evidence (from Scottish Inter-Collegiate Guidelines Network)
	Levels of evidence
1++	High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias
1+	Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
1-	Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
2++	High-quality systematic reviews of case-control or cohort studies High-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal
2+	Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal
2-	Case-control or cohort studies with a high risk of confounding, bias, or chance and a significant risk that the relationship is not causal
3	Nonanalytical studies, e.g. case reports, case series
4	Expert opinion

RCT = randomized controlled trial.

Table 2. Grades of Recommendation (from Scottish Inter-Collegiate Guidelines Network)
	Grades of recommendation
A	At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results
B	A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+
C	A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

RCT = randomized controlled

Table 3. Differential Diagnosis of Vitiligo
Halo naevus
Hypopigmented naevus
Idiopathic guttate hypomelanosis
Leprosy
Lichen sclerosus (for genital vitiligo)
Melanoma-associated leucoderma
Melasma
Mycosis fungoides-associated depigmentation
Naevus anaemicus
Naevus of Ito
Piebaldism
Pityriasis alba
Pityriasis versicolor
Postinflammatory depigmentation, e.g. scleroderma, psoriasis, atopic eczema
Post-traumatic depigmentation
Topical or drug-induced depigmentation
Tuberous sclerosis

Table 4. Skin Types*
Skin type	Typical features	Tanning ability
I	Pale white skin, blue/hazel eyes, blond/red hair	Always burns, does not tan
II	Fair skin, blue eyes	Burns easily, tans poorly
III	Darker white skin	Tans after initial burn
IV	Light brown skin	Burns minimally, tans easily
V	Brown skin	Rarely burns, tans darkly easily
VI	Dark brown or black skin	Never burns, always tans darkly

*from http://www.dermnetnz.org

Appendix 1.

Key recommendations:
The main points of note.

Introduction: D.J. Gawkrodger
Includes method of guideline development, aims, scope, audience, process, funding, declaration of interests and review.

Symptoms and Signs: A.D. Ormerod
What symptoms and signs are suggestive of vitiligo?

Wood's Light: A.D. Ormerod
What is the accuracy of Wood's light compared with naked eye examination in the diagnosis of vitiligo?

Natural history: A.V. Anstey
What is the natural history of vitiligo?

Quality of Life: L. Shaw, I. Mauri-Sole
What is the quality of life in patients with vitiligo compared with other skin diseases?

Scoring indices: M.J. Watts, M.E. Whitton
In all patients with vitiligo, what is the accuracy of a scoring index in showing the outcome of common treatments compared with simple photography?

Topical treatments: D.J. Gawkrodger
Includes: In all patients with vitiligo, what is the efficacy of applying betamethasone, clobetasol, fluocinolone, fluticasone or mometasone vs. placebo or other active treatment in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of applying calcipotriol or tacalcitol vs. placebo or an active treatment in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of applying tacrolimus or pimecrolimus vs. placebo or an active treatment in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of applying p-(benzyloxy)phenol (monobenzyl ether of hydroquinone) vs. placebo or an active treatment in terms of reducing areas of pigmentation?

Phototherapy: A.V. Anstey
Includes: In all patients with vitiligo, what is the efficacy of a course of narrowband UVB including high-intensity light sources compared with placebo in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of a course of PUVA or PUVA-sol compared with placebo in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of a course of khellin with sunlight UVA or UVB compared with PUVA or PUVA-sol in terms of progression, area reduction and quality of life score?

Late complications of PUVA or narrowband UVB therapy in patients with vitiligo: are patients who have received large doses of PUVA (more than 150 treatment sessions) or narrowband UVB (more than 150 treatment sessions) at increased risk of developing premalignant or malignant skin changes?

Combination Phototherapy: A.V. Anstey
Includes: In all patients with vitiligo, what is the efficacy of a course of narrowband UVB with a vitamin D analogue compared with narrowband UVB with placebo in terms of condition progression, area reduction and quality of life score?

In all patients with vitiligo, what is the efficacy of a course of PUVA with a vitamin D analogue compared with PUVA with placebo in terms of condition progression, area reduction and quality of life score?

Systemic Therapies: D.J. Gawkrodger
In all patients with vitiligo, what is the efficacy of systemic (i.e. orally and parenterally administered) treatments, including corticosteroids, ciclosporin and other immunosuppressive agents, in terms of condition progression, area reduction and quality of life score?

Surgical Treatments: A.D. Ormerod
In patients with vitiligo what is the efficacy of a skin graft and of various forms of placebo in terms of condition progression, area reduction and quality of life score? This may include punch grafts, full-thickness skin graft, split-thickness skin graft, autologous epidermal cell suspension, and autologous skin equivalent (commercial skin equivalent).

Psychological Treatments: L. Shaw, I. Mauri-Sole
In all patients with vitiligo, what is the efficacy of cognitive therapy vs. psychological support or no treatment in terms of condition progression, area reduction and quality of life score?

Research recommendations:
Areas for future research to improve treatment of vitiligo are suggested.

Final recommendations:
An approach to the overall management of vitiligo is outlined based on the evidence evaluated in this guideline.

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Guideline for the Diagnosis and Management of Vitiligo

In All Patients With Vitiligo, What is the Efficacy of Applying Calcipotriol or Tacalcitol vs. Placebo or an Active Treatment in Terms of Condition Progression, Area Reduction and Quality of Life Score?

Introduction

Methods

Evidence Statements

Evidence to Recommendations

Recommendation

Comments

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Guideline for the Diagnosis and Management of Vitiligo

In All Patients With Vitiligo, What is the Efficacy of Applying Calcipotriol or Tacalcitol vs. Placebo or an Active Treatment in Terms of Condition Progression, Area Reduction and Quality of Life Score?

Introduction

Methods

Evidence Statements

Evidence to Recommendations

Recommendation

Tables

Tables

Tables

Tables

Tables

Tables

References

Authors and Disclosures

Authors and Disclosures

Appendix

Appendix 1.

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