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H.9 Dithranol, Coal Tar and Vitamin D Analogues Combined with UVB

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H.9 Dithranol, Coal Tar and Vitamin D Analogues Combined with UVB Psoriasis Evidence Tables – Clinical Studies H.9 Dithranol, coal tar and vitamin D analogues combined with UVB H.9.1 Calcipotriol + NB-UVB versus Calcipotriol Reference Study type Number of Patient characteristics Interventio Compariso Length Outcome Source patients n n of measures follow- of up fundin g Not A.V. Roussaki- RCT Total N = 45 Inclusion criteria: Group A Group C 3 1º stated Schulze, C. month Outcome: Kouskoukis, E. Single centre, Patients with plaque psoriasis s Klimi, E. PASI Greece Pts randomised N=15 N=15 reduction Zafirou, A. to three Galanous, E. groups: A, B Exclusion criteria: Rallis. &C. Group B Calcipotriol Randomised: Pregnant women, history of skin Calcipotriol Calcipotriol PASI 50 not relevant cancer ointment ointment monotherapy Method not (UVA+calcipotri versus (Dovonex; (Dovonex stated ol) 50 µg/g, 50 µg/g, calcipotriol Other plus UVA1 Baseline characteristics of b.d.) b.d.) + NB- UVB* outcomes versus randomised patients: : calcipotriol Allocation (twice plus narrow- concealment: weekly) Clear band UVB in Calcipotriol Calcipotriol + Not mentioned the treatment NB-UVB of psoriasis. NB-UVB Non- Drugs Exptl. M/F 12/3 12/3 starting Blinding: responder Psoriasis Evidence Tables – Clinical Studies Cl in. Res , dose 80% 31(5/6):169- Not mentioned Age 44.93±6.48 49.53±22.01 MED and 174.2005 inc. by 20% Skin type 0/11/3/1 2/5/6/2 I/II/III/IV every 3 REFID: Washout sessions ROUSSAKISCH period: ULZE2005 90 days if using systemic *Cosmetico therapy, 30 days , 10 lamps if using topicals Helarium B1, 100 W each. 311- 313 nm Sample size calculation: Not stated ITT Analysis : Yes Drop outs: None Effect size PASI Calcipotriol (n=15) Calcipotriol + NB-UVB (n=15) Psoriasis Evidence Tables – Clinical Studies Number of patients achieving PASI 50 6 12 (p<0.05) Mean PASI at baseline 2.51 ±1.89 5.73 ±2.89 Mean PASI after treatment 1.27 ±1.25 2.51 ±2.34 Mean change in PASI -1.24 ±1.54 -3.22 ±1.70 Relapse at 3 months 2 Clear Calcipotriol (n=15) Calcipotriol + NB-UVB (n=15) Clear 4 2 Author conclusion The response to narrow-band UVB with calcipotriol was superior to calcipotriol monotherapy H.9.2 Calcipotriol + BB-UVB versus Calcipotriol Reference Study type Number Patient characteristics Intervention Comparison Length Outcome Source of of measures patients follow- of up funding Psoriasis Evidence Tables – Clinical Studies Not stated, K. Kragballe. RCT Total N Inclusion criteria: Calcipotriol Calcipotriol + 12 1º however Combination = 20 BB-UVB weeks Outcome: ointment of topical Single centre patients, Patients 18 years or older total: 8 provided by calcipotriol 40 body with symmetrically weeks of Clearance Leo Denmark N=20 halves Pharmaceutic (MC 903) and halves distributed chronic therapy, N=20 halves al Products UVB for plaque psoriasis. 4 week psoriasis post- Other vulgaris. Randomised: Calcipotriol therapy outcomes: Dermatologica Exclusion criteria: ointment 50 Calcipotriol (emollie Right/left µg/g twice ointment 50 . 181:211- comparison: patients nt only) 214.1990 Patients intolerant of UV daily µg/g twice daily randomised to have light, patients whose + BB-UVB UVB on right/left side psoriasis worsens with radiation 3 UV light exposure times a week REFID: KRAGBALLE19 Allocation 90 concealment: Baseline characteristics UVB 280-350 Not stated of randomised patients: nm (TL 60), suberythemoge nic starting at 50% MED Blinding: Sex: M/F 10/10 Open Mean Age, y 47 Disease 19 duration, y Washout: BSA 17 No systemic therapy involved, % for 2 months or topical therapy for at least 2 weeks prior to study Psoriasis Evidence Tables – Clinical Studies Sample size calculation: Not performed ITT Analysis : No Drop outs: 2 patients Effect size Clearance at week 8 Calcipotriol + BB-UVB Calcipotriol Number of halves cleared 7 3 Excellent improvement 9 12 17% of patients in calcipotriol alone group and 39% of patients in calcipotriol + UVB group (NS) 2 patients developed mild facial dermatitis with slight erythema and scaling around the mouth (group not stated) which disappeared during continue treatment After a 4 week post-therapy follow-up with emollient use only, i.e. study week 12, 12/13 patients were relapse-free Psoriasis Evidence Tables – Clinical Studies No other outcomes of interest Author conclusion These results show that the combination of topical calcipotriol and UVB radiation is well tolerated H.9.3 Calcitriol + BB-UVB versus Placebo + BB-UVB Reference Study type Number Patient characteristics Intervention Comparison Length Outcome Source of of measures patients follow- of up funding Grant from J. Ring, L. RCT Total N Inclusion criteria: N= 49 N= 53 8 weeks 1º Galderma Kowalzick, E. = 104 Outcome: Laboratori Christophers, Multicentre, Patients over 18 years of es age with chronic plaque- Global W.B. Schill, E. Germany Calcitriol Placebo Schopf, M. type psoriasis and global severity severity classification of ≥2 ointment (vehicle) + score Stander, H.H. (Silkis; 3 BB-UVB Wolff, P. (moderate) and skin type I, Randomised: II, II or IV µg/g, b.d.) + (290-320 Altmeyer. BB-UVB nm) Calcitriol 3 µg PASI -1 Method not stated (290-320 g ointment in nm) combination Exclusion criteria: Max. 24 with Other ultraviolet B Allocation concealment: Pregnant & breast-feeding sessions of women, use of topical Max. 24 UVB therapy outcomes: phototherapy Not stated for the treatments other than sessions of Adverse treatment of emulsifying ointments or UVB therapy events tar shampoos during study Psoriasis Evidence Tables – Clinical Studies plaque period, sensitisation to psoriasis: Washout: calcitriol or phototherapy, results of a 2 months (intralesional concomitant bacterial, comparative therapy or fungal or viral skin study. Br J photochemotherapy) conditions Dermatol . 144:495-499. 2001 Blinding: Baseline characteristics of randomised patients: Double-blind Stated no significant REF ID: difference in demographic RING2001 data between groups Sample size calculation: Not stated ITT Analysis : Modified ITT (patients who used study medication for at least 1 day, had a at least 1 UVB treatment and had at least 1 postbaseline assessment) Drop outs: 2 patients – outcomes not reported Psoriasis Evidence Tables – Clinical Studies Effect size Calcitriol + UVB (n=49) Placebo + UVB (n=53) Considerable improvement or clearing 22 11 % change in PASI 65% 43% Adverse events Calcitriol + UVB Placebo + UVB Adverse events 11 (22%) 13 (25%) Withdrawal due to adverse events 2 (rash, suspected diverticulitis) 1 (rash) Number of UVB treatments Calcitriol + UVB (n=49) Placebo + UVB (n=53) Range of number of UVB treatments 4-29 3-35 However, combination group exposed to 34% less radiation than placebo + UVB group. PASI scores decreased for both groups – scores for calcitriol treated patients significantly lower than those for vehicle group from week 4 onwards (P<0.05) Psori asis Evidence Tables – Clinical Studies Author conclusion: High levels of clinical efficacy and local tolerance demonstrated in this study indicate that calcitriol in combination with UVB has considerable potential for the management of patients with chronic plaque psoriasis, particularly on a long-term basis H.9.4 Calcipotriol + NB-UVB versus Placebo + NB-UVB Reference Study type Number Patient characteristics Intervention Comparison Length Outcome Source of of measures patients follow- of up fundin g Not W.K. Woo, K.E. RCT Total N = Inclusion criteria: Calcipotriol + Placebo + 10 1º stated McKenna. 50 NB-UVB NB-UVB weeks Outcome: Combination Single centre Patients aged ≥18 years with post- TL01 psoriasis (chronic plaque and/or treatme PASI N. Ireland guttate psoriasis) ultraviolet B N=25 N=25 nt phototherapy and topical Other calcipotriol for Randomised: Exclusion criteria: outcomes: TL01 TL01 psoriasis: a Computer-generated prospective Standard contraindications for phototherap phototherap PDI randomisation phototherapy; history of y + topical y + emollient randomized placebo- photosensitivity, skin calcipotriol (placebo) carcinomas, cataracts, epilepsy, controlled Adverse clinical trial. Br Allocation known hypercalcaemia, events J Dermatol . concealment: hypersensitivity to calcipotriol, Calcipotriol Emollient hypersensitivity to 149:146-150. Randomisation codes cream 50 cream 2003 cetomacrogol, cetostearyl, µg/g applied applied twice concealed by alcohol or paraffin Psoriasis Evidence Tables – Clinical Studies pharmacy until end of twice daily, daily trial max 100 g per week. REFID Baseline characteristics of WOO2003 randomised patients: Applied 2 hrs TL01 three Blinding: prior to UVB. times a week Calcipotriol Placebo + + TL01 Tl01 starting at Double-blinded: 70% MED Patients blinded, Mean age, 38.2 43.3 TL01 three with 20% y assessor blinded times a week increments Sex: M/F 12/13 16/9 starting at as tolerated, Mean 14.2 20.6 70% MED max. 20 Washout: duration of with 20% sessions disease, y increments 2 months – Mean 12.4 14.1 as tolerated, phototherapy/systemi baseline max. 20 c antipsoriatic therapy PASI sessions Sample size Stated no significant differences calculation: in demographic characteristics/baseline PASI Not stated ITT Analysis : Yes Drop outs: 6 in active group, 8 in control Psoriasis Evidence Tables – Clinical Studies Effect size Outcome Mean PASI score TL01 + calcipotriol TL01 + placebo P-value (active vs. placebo) Baseline 12.4 14.1 - 8th treatment session 4.8 11.6 P<0.01 14 th session 2.5 6.5 P<0.01 20 th session 1.3 2.3 NS Week 5 post-treatment 2.6 4.4 NS Week 10 post-treatment 3.1 4.3 NS Mean difference in PASI score TL01 + calcipotriol TL01 + placebo Difference (95%
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