Table A

Table B

Additional references

Marked improvement (patient)

Marked improvement (Investigator)
 

Table A Characteristics of randomised controlled trials. Regimen is twice daily unless stated otherwise
 

Trial
Design
Interventions
Duration of follow up (weeks)
No randomised
 
Outcome measures (efficacy)
Calcipotriol 0.005%
Control
Calcipotriol
Control
Psorasis area and severity index
Overall assessment
Investigator
Patient
Kragballe et al 1989W1Double blind, bilateral comparisonOintmentVehicle ointment
8
10
10
 
NR
Yes
NR
Dubertret et al 1992w2Double blind, bilateral comparisonOintmentVehicle ointment 
2, 4
65
65
 
Yes
Yes
Yes
Highton et al 1995w3Double blind, parallel groupOintmentVehicle ointment 
1, 2, 4, 6, 8
139
138
 
NR
Yes
NR
Guzzo et al 1996w4Double blind, parallel groupOintmentVehicle ointment 
1, 2, 4, 8
38
40
 
NR
Yes
NR
Harrington et al 1996w5Double blind, parallel group*CreamVehicle cream 
8
161
87
 
Yes
NR
Yes
Oranje et al 1997w6Double blind, parallel groupOintmentVehicle ointment 
2, 4, 6, 8
43
34
 
Yes
Yes
Yes
Pariser et al 1996w7Double blind, parallel groupOintment once dailyVehicle ointment once daily
1, 2, 4, 6, 8
118
117
 
NR
Yes
NR
Kang et al 1998w8Double blind, parallel groupOintmentVehicle ointment 
6
15
15
 
NR
Yes
NR
Kragballe et al 1991w9Double blind, bilateral comparisonOintment0.1% betamethasone valerate ointment 
2, 4, 6
345
345
 
Yes
NR
Yes
Cunliffe et al 1992w10Double blind, parallel groupOintment0.1% betamethasone valerate ointment 
2, 4, 6
205
204
 
Yes
NR
Yes
Vladimirov et al 1994w11Double blind, parallel groupOintment0.1% betamethasone valerate ointment 
6
32
28
 
Yes
NR
NR
Molin et al 1997w12Double blind, parallel groupCream0.1% betamethasone valerate cream 
4, 8
210
211
 
Yes
Yes
Yes
Kragballe et al 1998w37Double blind, parallel group†Cream 0.005% calcipotriol cream morning, 0.05% clobetasone butyrate cream at night
2, 4, 8
174
175
 
Yes
Yes
Yes
Ortonne 1994w13Double blind, parallel groupOintment 0.005% calcipotriol ointment morning, 0.1% betamethasone dipropionate ointment at night
1, 2, 4, 6
97
91
 
Yes
Yes
NR
Ruzicka and Lorenz 1998w14Double blind, parallel groupOintment0.005% calcipotriol ointment morning, 0.1% betamethasone valerate ointment at night
2, 4
87
82
 
Yes
Yes
NR
Kragballe et al 1998w37Double blind, parallel group†Cream 0.005% calcipotriol cream morning, 0.05% betamethasone valerate cream at night
2, 4, 8
174
176
 
Yes
Yes
Yes
Landi et al 1993w15Double blind, parallel groupOintment 0.05% clobetasol propionate ointment 
2, 4, 6
20
20
 
Yes
NR
NR
Landi 1993w16Open parallel groupOintment 0.05% clobetasol propionate ointment 
2, 4, 6
60
60
 
Yes
NR
NR
Medansky et al 1996w17Double blind, bilateral comparisonOintment 0.05% diflorasone diacetate ointment 
3
134
134
 
NR
Yes
NR
Kim et al 1994w18Double blind, bilateral comparisonOintment 0.25% desoxymethasone ointment 
2, 4, 6, 8
10
10
 
Yes
NR
NR
Lebwohl et al 1996w19Double blind, parallel group*Ointment 0.05% halobetasol ointment versus 0.005% calcipotriol ointment morning, 0.05% halobetasol ointment at night
2, 2
42, 42
43, 42
 
NR, NR
Yes, yes
NR, NR
Bruce et al 1994w20Double blind, parallel groupOintment 0.05% fluocinonide ointment
2, 4, 6
57
56
 
NR
Yes
NR
Crosti et al 1997w21Double blind, parallel groupOintment Betamethsone dipropionate, 3% salicylic acid
6
80
80
 
Yes
Yes
NR
Baiocchi et al 1997w22Open bilateral comparisonOintment 0.005% ointment once daily
8
132
132
 
Yes
NR
NR
Kragballe et al 1998w37Double blind, parallel group†Cream 0.005% cream once daily
2, 4, 8
174
174
 
Yes
Yes
Yes
Meyrat and Müller 1996w23Open parallel groupOintment 0.005% calcipotriol cream morning, 0.005% ointment at night
3, 6
45
46
 
Yes
NR
NR
Bourke et al 1997w24Double blind, parallel groupOintment 0.0003% calcitriol ointment 
1, 2, 4, 6, 8
12
12
 
Yes
NR
NR
de Simone et al 1993w25Double blind, parallel groupOintment 5% coal tar cream 
6
15
15
 
Yes
NR
NR
Tham et al 1994w26Single blind, bilateral comparisonOintment White soft paraffin morning, coal tar 15% v/w in aqueous cream at night
2, 4, 6
30
30
 
Yes
Yes
Yes
Pinheiro 1997w27Open parallel groupOintment 5% coal tar, 2% allantoin, and 0.5% hydrocortisone cream 
8
69
63
 
NR
Yes
NR
Berth-Jones et al 1992w28Open parallel groupOintment 0.1-2% dithranol cream 30 minutes once daily
2, 4, 8
239
239
 
Yes
Yes
Yes
Grattan et al 1997w29Open bilateral comparisonOintment 0.1-5% dithranol gel 
4
25
25
 
NR
NR
NR
Lister et al 1997w30Single blind, parallel groupOintment 1-3% dithranol cream 30 minutes once daily
8
89
82
 
NR
NR
NR
Wall et al 1998w31Open parallelOintment 0.1-2% dithranol cream 30 minutes to 1 hour once daily
12
161
144
 
NR
Yes
Yes
Veien et al 1997w32Double blind, parallel groupOintment 0.0004% tacalcitol ointment once daily
8
145
142
 
NR
Yes
Yes
Kragballe 1990w33Open bilateral comparisonOintment 0.005% calcipotriol ointment twice daily and ultraviolet B 3 times weekly
8
20
20
 
NR
Yes
NR
Kersher et al 1994w34Open bilateral comparisonOintment 0.005% calcipotriol ointment twice daily and ultraviolet B 5 times weekly
2
20
20
 
Yes
NR
NR
Molin et al 1993w35Open bilateral comparisonOintment 0.005% calcipotriol ointment twice daily and ultraviolet B 3 times weekly
2, 4, 6, 8
101
101
 
Yes
Yes
Yes
Bourke et al 1997w36Open parallel group*Ointment 100 g/week0.005% calcipotriol ointment 100g/week and ultraviolet B three times weekly, ultraviolet B three times weekly
2, 4 and 2, 4
10 in each
10 in each
 
Yes, yes
NR, NR
NR, NR

NR=not reported.

*Three armed head to head comparison.

†Four armed head to head comparison.
 
 

Table B Comparison of withdrawal rates and risk of adverse effects (95% confidence intervals)
 


 
 

Comparison

Withdrawal (total)
Withdrawal

(adverse effects)

Irritation
Exacerbation
Lesional or perilesional
Facial or scalp
Calcipotriol v placebo
Crude rate
30/396 v 42/314
11/461 v 13/379
60/433 v 45/349
22/294 v 0/211
10/471 v 16/389
Weighted rate ratio
0.53 (0.34 to 0.84)*
0.73 (0.34 to 1.58)
1.00 (0.69 to 1.44)
4.39 (1.05 to 18.42)*
0.57 (0.27 to 1.21)
Weighted rate difference
0.05 ( 0.10 to 0.01)*
0.01 ( 0.03 to 0.02)
0.02 ( 0.03 to 0.06)
0.05 ( 0.01 to 0.11)
0.01 ( 0.04 to 0.01)
Calcipotriol v potent topical corticosteroid
Crude rate
49/514 v 36/514
13/817 v 8/816
110/859 v 41/859
25/415 v 1/415
18/859 v 24/859
Weighted rate ratio
1.33 (0.88 to 1.99)
1.63 (0.68 to 3.91)
2.49 (1.76 to 3.53)*
16.05 (3.09 to 83.36)*
0.74 (0.39 to 1.40)
Weighted rate difference
0.03 (0.00 to 0.06)
0.00 (0 to 0.01)
0.10 (0.03 to 0.17)*†
0.06 ( 0.02 to 0.13)
0.00 ( 0.01 to 0.01)
Calcipotriol v very potent topical corticosteroid
Crude rate
20/80 v 48/80
3/80 v 2/80
3/80 v 1/80
0/80 v 2/80
0/80 v 0/80
Weighted rate ratio
0.42 (0.28 0.63)*
1.40 (0.28 to 6.91)
2.28 (0.33 to 15.80)
0.33 (0.04 to 3.12)
1 (0.06 to 15.63)
Weighted rate difference
0.34 ( 0.47 to 0.20)*
0.01 ( 0.05 to 0.07)
0.02 ( 0.03 to 0.08)
0.02 ( 0.06 to 0.02)
0 ( 0.03 to 0.03)
Calcipotriol v moderate topical corticosteroid plus calcipotriol
Crude rate
17/174 v 12/175
6/174 v 3/175
55/174 v 28/175
17/174 v 9/175
NR
Rate ratio
1.42 (0.70 to 2.89)
2.01 (0.51 to 7.92)
1.98 (1.32 to 2.96)*
1.90 (0.87 to 4.15)
NR
Rate difference
0.03 ( 0.03 to 0.09)
0.02 ( 0.02 to 0.05)
0.16 (0.07 to 0.24)*‡
0.05 ( 0.01 to 0.10)
NR
Calcipotriol v potent topical corticosteroid plus calcipotriol
Crude rate
30/400 v 20/391
14/358 v 6/349
86/313 v 30/309
17/174 v 5/176
1/139 v 0/133
Weighted rate ratio
1.43 (0.82 to 2.48)
2.25 (0.87 to 5.82)
2.70 (1.84 to 3.96)*
3.44 (1.30 to 9.12)*
1.86 (0.16 to 21.93)
Weighted rate difference
0.03 ( 0.01 to 0.06)
0.02 (0.00 to 0.04)
0.18 (0.12 to 0.24)*§
0.07 (0.02 to 0.12)*¶
0.01 ( 0.02 to 0.03)
Calcipotriol v betamethasone dipropionate plus 3% salicylic acid
Crude rate
20/80 v 17/80
6/80 v 2/80
8/80 v 0/80
NR
NR
Rate ratio
1.18 (0.67 to 2.08)
3 (0.62 to 14.42)
17 (0.10 to 289.67)*
NR
NR
Rate difference
0.04 ( 0.09 to 0.17)
0.05 ( 0.02 to 0.12)
0.10 (0.03 to 0.17)* **
NR
NR
Calcipotriol twice daily v once daily
Crude rate
32/306 v 30/306
13/306 v 14/306
72/306 v 53/306
17/174 v 8/174
3/132 v 3/132
Weighted rate ratio
1.06 (0.66 to 1.71)
0.93 (0.44 to 1.95)
1.35 (0.99 to 1.84)
2.13 (0.94 to 4.79)
1 (0.21 to 4.86)
Weighted rate difference
0.01 ( 0.04 to 0.05)
0.00 ( 0.04 to 0.03)
0.06 (0.00 to 0.11)
0.05 (0.00 to 0.11)
0 ( 0.04 to 0.04)
Calcipotriol v calcitriol
Crude rate
4/12 v 4/12
0/12 v 0/12
NR
NR
NR
Rate ratio
1 (0.32 to 3.1)
1 (0.02 to 46.71)
NR
NR
NR
Rate difference
0 ( 0.38 to 0.38)
0 ( 0.15 to 0.15)
NR
NR
NR
Calcipotriol v coal tar 5%, allantoin 2%, and hydrocortisone 0.5%
Crude rate
4/69 v 6/63
1/69 v 3/63
13/69 v 7/63
NR
1/69 v 1/63
Rate ratio
0.61 (0.18 to 2.06)
0.30 (0.03 to 2.85)
1.70 (0.72 to 3.98)
NR
0.91 (0.06 to 14.29)
Rate difference
0.04 ( 0.13 to 0.05)
0.03 ( 0.09 to 0.03)
0.08 ( 0.04 to 0.20)
NR
0.00 ( 0.04 to 0.04)
Calcipotriol v coal tar
Crude rate
0/15 v 0/15
1/45 v 0/45
3/45 v 0/45
0/45 v 0/45
1/45 v 1/45
Rate ratio
1 (0.02 to 47.38)
1.93 (0.17 to 22.26)
3.44 (0.34 to 35.37)
1 (0.06 to 15.47)
0.99 (0.11 to 9.11)
Rate difference
0 ( 0.12 to 0.12)
0.02 ( 0.05 to 0.09)
0.05 ( 0.04 to 0.13)
0 ( 0.06 to 0.06)
0.01 ( 0.07 to 0.09)
Calcipotriol v short contact dithranol
Crude rate
65/489 v 104/465
15/489 v 38/465
61/353 v 149/346
10/239 v 1/239
3/239 v 3/239
Weighted rate ratio
0.59 (0.45 to 0.76)*
0.37 (0.21 to 0.66)*
0.43 (0.33 to 0.55)*
10 (1.29 to 77.51)*
1 (0.20 to 4.91)
Weighted rate difference
0.07 ( 0.12 to 0.03)*
0.04 ( 0.07 to 0.02)*
0.26 ( 0.40 to 0.13)* ††
0.04 (0.01 to 0.06)*‡‡
0 ( 0.02 to 0.02)
Calcipotriol v tacalcitol
Crude rate
5/145 v 4/142
5/145 v 4/142
NR
NR
NR
Rate ratio
1.22 (0.34 to 4.47)
1.22 (0.34 to 4.47)
NR
NR
NR
Rate difference
0.01 ( 0.03 to 0.05)
0.01 ( 0.03 to 0.05)
NR
NR
NR
Calcipotriol v ultraviolet B phototherapy plus calcipotriol
Crude rate
NR
NR
14/101 v 16/101
3/121 v 3/121
2/101 v 2/101
Weighed rate ratio
NR
NR
0.88 (0.45 to 1.70)
1 (0.21 to 4.67)
1 (0.14 to 6.96)
Weighted rate difference
NR
NR
0.02 ( 0.12 to 0.08)
0 ( 0.03 to 0.03)
0 ( 0.04 to 0.04)

NR=not reported.

*P£0.05 for difference in rates.

Number needed to treat: †10 (6 to 34); ‡7 (4 to 15); §6 (4 to 8); ¶15 (9 to 54); **11 (6 to 34);††–4 (–8 to –3); ‡‡27 (15 to 91).
 

Additional references

w1 Kragballe K. Treatment of psoriasis by the topical application of the novel cholecalciferol analogue calcipotriol (MC903). Arch Dermatol 1989;125:1647-52.

w2 Dubertret L, Wallach D, Souteyrand P, Perussel M, Kalis B, Meynadier J, et al. Efficacy and safety of calcipotriol (MC903) ointment in psoriasis vulgaris. J Am Acad Dermatol 1992;27:983-8.

w3 Highton A, Quell J, and The Calcipotriene Study Group. Calcipotriene ointment 0.005% for psoriasis: a safety and efficacy study. J Am Acad Dermatol 1995;32:67-72.

w4 Guzzo C, Lazarus G, Goffe B, Katz HI, Lowe NJ, Pincus SH. Topical calcipotriene has no short-term effect on calcium and bone metabolism of patients with psoriasis. J Am Acad Dermatol 1996;34:429-33.

w5 Harrington CI, Goldin D, Lovell CR, van de Kerkhof P, Nieboer C, Austad J, et al. Comparative effects of two different calcipotriol (MC903) formulations versus placebo in psoriasis vulgaris. A randomised, double-blind, placebo-controlled, parallel group multi-centre study. J Eur Acad Dermatol Venereol 1996;6:152-8.

w6 Oranje AP, Marcoux D, Svensson Å, Prendiville J, Krafchik B, Toole J, et al. Topical calcipotriol in childhood psoriasis. J Am Acad Dermatol 1997;36:203-8.

w7 Pariser DM, Pariser RJ, Breneman D, Lebwohl M, Kalb R, Moore J, et al. Calcipotriene ointment applied once a day for psoriasis: a double-blind, multicenter, placebo-controlled study. Arch Dermatol 1996;132:1527.

w8 Kang S, Yi S, Griffiths CEM, Fancher L, Hamilton TA, Choi JH. Calcipotriene-induced improvement in psoriasis is associated with reduced interleukin-8 and increased interleukin-10 levels within lesions. Br J Dermatol 1998;138:77-83.

w9 Kragballe K, Gjertsen BT, de Hoop D, Karlsmark T, van de Kerkhof PCM, Larkö O, et al. Double-blind, right/left comparison of calcipotriol and betamethasone valerate in treatment of psoriasis vulgaris. Lancet 1991;337:193-6.

w10 Cunliffe WJ, Berth-Jones J, Claudy A, Fairiss G, Goldin D, Gratton D, et al. Comparative study of calcipotriol (MC903) ointment and betamethasone 17-valerate ointment in patients with psoriasis vulgaris. J Am Acad Dermatol 1992;26:736-43.

w11 Vladimirov VV, Tcherjomukchina IG, Kurjanova ON, Menshikova LV, Mazina NM. Efficacy of calcipotriol ointment compared to betamethasone 17-valerate ointment in the treatment of psoriasis [abstract]. In: Skin therapy update ‘94.Crete, Greece;1994:219.

w12 Molin L, Cutler TP, Helander I, Nyfors B, Downess N and the Calcipotriol Study Group. Comparative efficacy of calcipotriol (MC903) cream and betamethasone 17-valerate cream in the treatment of chronic plaque psoriasis. A randomized, double-blind, parallel group multicentre study. Br J Dermatol 1997;136:89-93.

w13 Ortonne JP. Psoriasis: nouvelle modalité thérapeutique par le calcipotriol plus le dipropionate de bétaméthasone. Nouv Dermatol 1995;14:746-51.

w14 Ruzicka T, Lorenz B. Comparison of calcipotriol monotherapy and a combination of calcipotriol and betamethasone valerate after 2 weeks’ treatment with calcipotriol in the topical therapy of psoriasis vulgaris: a multicentre, double-blind, randomized study. Br J Dermatol 1998;138:254-8.

w15 Landi G, Pierleoni M, Polverelli M, Fioravanti F. Il calcipotriol, nuovo topico nella terapia della psoriasi: studio controllato versus clobetasol. G Ital Dermatol Venereol 1993a;128:LXXXIX-XCIII.

w16 Landi G. Efficacy and safety of calcipotriol ointment compared to clobetazole ointment in psoriasis vulgaris [abstract]. Presented at the 3rd congress of the European Academy of Dermatology and Venereology. Copenhagen, Denmark;1993:199.

w17 Medansky RS, Greenspan A, Kraus SJ, Plott RT. The comparative efficacy of diflorasone diacetate ointment 0.05% (Psorcon) vs calcipotriene ointment (Dovonex) in the treatment of psoriasis. J Geriatr Dermatol 1996;4:20-4.

w18 Kim JY, You YH, Kim TY, Kim CW. Comparative study of calcipotriol and desoxymethasone ointments in the treatment of psoriasis vulgaris. The clinical effect and immunohistochemical change. Kor J Dermatol 1994;32:1054-63.

w19 Lebwohl M, Siskin SB, Epinette W, Breneman D, Funicella T, Kalb R, et al. A multicenter trial of calcipotriene ointment and halobetasol ointment compared with either agent alone for the treatment of psoriasis. J Am Acad Dermatol 1996;35:268-9.

w20 Bruce S, Epinette WW, Funicella T, Ison A, Jones EL, Loss R, et al. Comparative study of calcipotriene (MC903) ointment and fluocinonide ointment in the treatment of psoriasis. J Am Acad Dermatol 1994;31:755-9.

w21 Crosti C, Finzi AF, Mian E, Scarpa C. Calcipotriol in psoriasis vulgaris: a controlled trial comparing betamethasone dipropionate + salicylic acid. Int J Dermatol 1997;36:537-41.

w22 Baiocchi R, Bertani E, Biggio P, Calandra P, de Marchi R, Franchi A, et al. Studio controllato per emiparti sull'efficacia e la tollerabilità di calcipotriolo unguento 1 applicazione/die versus 2 applicazioni/die, nella psoriasi volgare. G Ital Dermatol Venereol 1997;132:139-47.

w23 Meyrat R, Müller I. Daivonex salbe zwei mal täglich versus Daivonex creme morgens und Daivonex salbe abends. Ars Medici 1996;20:1218-20.

w24 Bourke JF, Iqbal SJ, Hutchinson PE. A randomized double-blind comparison of the effects on systemic calcium homeostasis of topical calcitriol (3 (g/g) and calcipotriol (50 (g/g) in the treatment of chronic plaque psoriasis vulgaris. Acta Derm Venereol (Stockh) 1997;77:228-30.

w25 de Simone C, Guerriero C, Morini P, Venier A. Il calcipotriol nella terapia locale della psoriasi. G Ital Dermatol Venereol 1993;128:IC-CIII.

w26 Tham SN, Lun KC, Cheong WK. A comparative study of calcipotriol ointment and tar in chronic plaque psoriasis. Br J Dermatol 1994;131:673-7.

w27 Pinheiro N. Comparative effects of calcipotriol ointment (50 (g/g) and 5% coal tar / 2% allantoin / 0.5% hydrocortisone cream in treating plaque psoriasis. Br J Clin Pract 1997;51:16-9.

w28 Berth-Jones J, Chu AC, Dodd WAH, Ganpule M, Griffiths WAD, Haydey RP, et al. A multicentre, parallel-group comparison of calcipotriol ointment and short-contact dithranol therapy in chronic plaque psoriasis. Br J Dermatol 1992;127:266-71.

w29 Grattan CEH, Hallam F, Whitehead M. A new aqueous dithranol gel for psoriasis: comparison with placebo and calcipotriol ointment. J Dermatol Treat 1997;8:11-5.

w30 Lister RK, Woodrow SL, Hughes JH, Cerio R, Norris PG, Griffiths CEM, et al. Can dithranol have a lasting effect and be more acceptable to patients? Micanol cream a trial of 171 patients with psoriasis [abstract]. Br J Dermatol 1997;137(suppl 50):17.

w31 Wall ARJ, Poyner TF, Menday AP. A comparison of treatment with dithranol and calcipotriol on the clinical severity and quality of life in patients with psoriasis. Br J Dermatol 1998;139:1005-11.

w32 Veien NK, Bjerke JR, Rossmann-Ringdahl I, Jakobsen HB. Once daily treatment of psoriasis with tacalcitol compared with twice daily treatment with calcipotriol. A double-blind trial. Br J Dermatol 1997;137:581-6.

w33 Kragballe K. Combination of topical calcipotriol (MC903) and UVB radiation for psoriasis vulgaris. Dermatologica 1990;181:211-4.

w34 Kersher M, Plewig G, Lehmann P. Kombinationstherapie der Psoriasis vulgaris mit einem Schmalspektrum UV-B-Strahler (Philips TL 01, 311nm) und calcipotriol. Akt Dermatol 1994;20:151-4.

w35 Molin L, Liberton H, van Weelden H, Austad J, McFadden N, Thune P, et al. Does UVB improve the effect of calcipotriol in psoriasis? Presented at the 2nd international symposium on calcipotriol [abstract]. Monaco, 1993.

w36 Bourke JF, Iqbal SJ, Hutchinson PE. The effects of UVB plus calcipotriol on systemic calcium homeostasis in patients with chronic plaque psoriasis. Clin Exp Dermatol 1997;22:259-61.

w37 Kragballe K, Barnes L, Hamberg KJ, Hutchinson P, Murphy F, Møller S, et al. Calcipotriol cream with or without concurrent topical corticosteroid in psoriasis: tolerability and efficacy. Br J Dermatol 1998;139:649-54.
 

Marked improvement (patient)

  

Marked improvement (Investigator)