Psoriasis

Report Year

Trial Code

Trial Title

Clinicaltrials.gov

EudraCTno.

Source

2018

LP0058-1072

LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

NCT02888236

2015-005279-25

Summary

Plain summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

Tablet

Trial Phase

2a

Population

adults

2017

LP0133-1182

A Phase 2a, Proof of Concept Trial, testing twice daily application of LEO 124249 ointment 30mg/g in the treatment of mild to moderate inverse psoriasis

NCT02695940

2015-002098-40

Summary

Active Substance

LEO 124249

LEO Pharma Product

N/A

Formulation

Ointment

Trial Phase

2a

Population

adults

2016

LP0076-1128

Efficacy and Safety of LEO 80185 gel (calcipotriol hydrate plus betamethasone dipropionate) in japanese subjects with psoriasis vulgaris

NCT02668692

N/A

Summary

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel & ointment

Trial Phase

3

Population

adults

2016

LP0053-1227

A psoriasis plaque test trial with LEO 90100 compared to Betesil® in patients with psoriasis vulgaris

NCT02518048

2015-001798-41

Summary

Report

Publication

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

2a

Population

adults

2016

LP0053-1030

Patient insights following use of LEO 90100 aerosol foam and Daivobet® gel in subjects with psoriasis vulgaris

NCT02310646

2014-003072-24

Summary

Questionnaires

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

foam & gel

Trial Phase

3b

Population

adults

2016

LP0113-1123

A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris

NCT02416258

2014-004759-30

Summary

Active Substance

calcipotriol + betamethasone dipropionate & calcipotriol & betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

spray, foam & gel

Trial Phase

2a

Population

adults

 

2015

LP0058-1005

LP0058-1005 - A phase 1, open-label, four-way crossover and food-effect study of LEO 32731 in healthy subjects when administered as an immediate and modified release formulation

NCT02126371

2013-004346-41

Summary

Active Substance

LEO 32731

LEO Pharma Product

N/A

Formulation

tablet & capsule

Trial Phase

1

Population

adults

2015

LP0053-1003

LEO 90100 aerosol foam compared to calcipotriol plus betamethasone dipropionate gel in subjects with psoriasis vulgaris

NCT02132936

2013-004686-14

Summary

Report

Publication 
Plain summary

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

foam & gel

Trial Phase

3b

Population

adults

2014

LP0053-66

Combined cumulative irritation potential and repeat insult patch test of LEO 90100 areosol foam

NCT01935869

2012-004264-21

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

1

Population

adults

2014

LP0053-1001

LEO 90100 compared to vehicle in subjects with psoriasis vulgaris

NCT01866163

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

3a

Population

adults

2014

LP0053-69

A vasoconstriction study with LEO 90100

NCT01946386

2012-002660-28

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

foam & ointment

Trial Phase

1

Population

adults

2013

LEO 90100-30

Effect of LEO 90100 on the HPA axis and calcium metabolism in subjects with extensive psoriasis vulgaris

NCT01600222

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

2

Population

adults

2013

LP0076-57

A short-contact plaque test study with Daivobet® gel in psoriasis vulgaris

NCT01607853

2012-001507-21

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2a

Population

adults

2013

MCB 0903

Efficacy and safety of LEO 90105 ointment (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with psoriasis vulgaris

NCT01422434

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

3

Population

adults

2013

LEO 90100-35

LEO 90100 compared with calcipotriol plus betamethasone dipropionate ointment, LEO 90100 vehicle and ointment vehicle in subjects with psoriasis vulgaris

NCT01536886

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

foam & ointment

Trial Phase

2

Population

adults

2013

MBL 0801

Fucidin® versus flucoxacillin in a skin and soft tissue infection

NCT01083758

2008-007606-11

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2

Population

adolescents

2013

MCB 0904

The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris

NCT01768013

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

2

Population

adults

2013

LEO 90100-7

LEO 90100 in treatment of psoriasis vulgaris

NCT01536938

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar®

Formulation

foam

Trial Phase

2

Population

adults

2013

MBL 0412 INT

Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in adolescent subjects (aged 12 to 17 years) with scalp psoriasis

NCT01120223

2008-005456-24

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2

Population

adolescents

2012

MCB 0501 INT

Safety and efficacy of Taclonex ointment in adolescent patients (aged 12 to 17 years) with psoriasis vulgaris

NCT00817219

2006-002693-21

Summary

Report

Active Substance

calcipotriol+ betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

2

Population

adolescents

2011

LEO 80185-G24

Effect of LEO 80185 gel on the HPA axis and calcium metabolism in subjects with extensive psoriasis vulgaris

NCT01229098

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2

Population

adults

2011

LEO 90100-01

A psoriasis plaque test study with LEO 90100 cutaneous spray, ointment, in psoriasis vulgaris

NCT01347255

2011-000153-23

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Enstilar® & Daivobet®*

Formulation

foam & ointment

Trial Phase

2a

Population

adults

2011

LEO 80185-G23

Calcipotriol plus betamethasone dipropionate topical suspension compared to betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle and the topical suspension vehicle alone in psoriasis vulgaris

NCT01188928

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

3

Population

adults

2011

MBL 0802 CN

Multicentre, randomized, investigator-blinded, parallel-group study to assess the efficacy and safety of Xamiol® gel compared to calcipotriol scalp solution in patients with scalp psoriasis

NCT01195831

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

gel & scalp solution

Trial Phase

3

Population

adults

2011

MCB 0902

Multiple dose study of LEO 90105 – calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

NCT01293383

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

1

Population

adults

2010

MCO 0901 FR

An irritation study with new calcipotriol ointment formulations in healthy subjects

NCT01105234

2009-017394-38

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

cream

Trial Phase

1

Population

adults

2009

PLQ 002

A plaque test comparing 4 steroids with Daivobet® ointment and a vehicle control for the treatment of psoriasis vulgaris.

NCT00845481

2008-005487-13

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

2

Population

adults

2009

LEO 80185-G21

Efficacy and safety of calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris

NCT00670241

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

3

Population

adults

2009

PLQ 001

A plaque test comparing three marketed products and two products in development and a vehicle control for the treatment of psoriasis vulgaris

N/A

2007-005463-10

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

gel & ointment

Trial Phase

2

Population

adults

2008

MBL 0202 INT

Calcipotriol plus betamethasone dipropionate gel compared to betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone in psoriasis vulgaris

NCT00263718

2005-003215-78

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2

Population

adults

2007

MBL 0502 US

Calcipotriene plus betamethasone dipropionate gel compared to the gel vehicle in scalp psoriasis, in patients receiving calcipotriene plus betamethasone dipropionate ointment for psoriasis vulgaris of trunk/limbs

NCT00279162

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

Ointment

Trial Phase

3

Population

adults

2007

WCO 0501 US

A randomized, double-blind, active-controlled study to evaluate the efficacy of Taclonex® (calcipotriene, 0.005% and betamethasone, 0.05%) ointment compared to Dovonex® (calcipotriene ointment, 0.005%) in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

2007

MC 9305 INT

A comparative study of the efficacy, tolerability and safety of 1: calcipotriol cream II (25 μg/g), 2: calcipotriol cream II (50 μg/g) and 3: placebo cream II in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

cacipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

2007

MCB 0402 INT

Different treatment regimens of calcipotriol cream and combination (calcipotriol/betamethasone dipropionate) ointment in psoriasis vulgaris

NCT00216892

2004-004577-28

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

ointment & cream

Trial Phase

4

Population

adults

 

2007

MBL 0601 FR

Assessment of the atrophogenic potential and dermal tolerance of Daivobet*/Dovobet gel compared with Diprosone® ointment

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0404 FR

Effect of Daivobet/Dovobet gel on the HPA axis and calcium metabolism in patients with extensive scalp psoriasis

N/A

2005-002733-12

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel & ointment

Trial Phase

1

Population

adults

2007

MBL 0403 FR

In vivo bioequivalence study of betamethasone dipropionate in Daivobet/Dovobet gel and Diprosone ointment according to FDA guideline for vasoconstrictor bioassay

N/A

2004-000036-84

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2007

MBL 0407 INT

Long-term treatment of scalp psoriasis with calcipotriol plus betamethasone dipropionate gel

NCT00216879

2004-002861-19

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

3

Population

adults

2007

MBL 0503 INT

Calcipotriol plus betamethasone dipropionate gel compared to Daivonex/Dovonex scalp solution in patients with scalp psoriasis

NCT00243464

2005-002864-27

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

gel & scalp solution

Trial Phase

3

Population

adults

2006

MBL 0402 UK

Assessment of the atrophogenic potential and dermal tolerance of Daivobet/Dovobet gel compared with Diprosone® ointment

N/A

2005-001 225-29

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0302 FR

Repeat insult patch test with Daivobet/Dovobet gel including 21-days cumulative irritation study and sensitisation potential in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0301 UK

Assessment of the photosensitisation potential of Daivobet/Dovobet gel containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

N/A

2005-001226-91

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2006

MBL 0405 INT

Calcipotriol plus betamethasone dipropionate gel compared to betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone in scalp psoriasis

NCT00216827

2004-002015-86

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

3

Population

adults

2006

MBL 0406 INT

Calcipotriol plus betamethasone dipropionate gel compared to betamethasone dipropionate in the gel vehicle and calcipotriol in the gel vehicle in scalp psoriasis

NCT00216840

2004-002152-33

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

3

Population

adults

2005

MCO 9803 NL

Calcipotriol intensified treatment versus dithranol intensified treatment in patients with psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®*/Dovonex®

Formulation

ointment

Trial Phase

4

Population

adults

2005

MBL 0303 FR

Phototoxicity study: Assessment of the phototoxic potential of Daivobet/Dovobet (calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) gel

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

1

Population

adults

2005

MBL 0401 INT

Calcipotriol plus betamethasone dipropionate gel in scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

gel

Trial Phase

2

Population

adults

2004

MCB 0102 INT

Calcipotriol/betamethasone dipropionate in psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

3

Population

adults

2004

MCB 0201 FR

Effect of calcipotriol/betamethasone dipropionate ointment compared to betamethasone dipropionate ointment on the HPA axis in patients with psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

1

Population

adults

2004

MCB 0306 UK

Daivobet*/Dovobet ointment / UV penetration study in humans - detection of erythema induced by UV light, a within subject comparison of investigational materials against untreated skin

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. &calcipotriol

LEO Pharma Product

Daivobet®*   & Daivonex®/ Dovonex®

Formulation

ointment & scalp solution

Trial Phase

1

Population

adults

2003

MCB 0202 FR

Repeat insult patch test with Daivobet/ Dovobet ointment - a study on the sensitisation potential of Daivobet*/Dovobet ointment and the ointment vehicle when applied on healthy skin in 200 healthy subjects

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0204 FR

Photo-allergy test: Assessment of the photosensitisation potential of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

1

Population

adults

2003

MCB 0203 FR

21-day cumulative irritation test: Assessment of the local skin tolerability, after repeated application of Daivobet/Dovobet ointment (calcipotriol 50 µg/g and betamethasone (as dipropionate) 0.5 mg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®*

Formulation

ointment

Trial Phase

1

Population

adults

2002

MCB 0001 INT

Calcipotriol/betamethasone once daily versus tacalcitol once daily in psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®* & Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3b

Population

adults

2002

MCB 0101 FR

Photo-toxicity study: Assessment of the phototoxic potential of Daivobet®/Dovobet® ointment (betamethasone dipropionate 0.5mg/g and calcipotriol 50μg/g)

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivobet®

Formulation

ointment

Trial Phase

1

Population

adults

2001

MCS 9505 SE

Calcipotriol and pityrosporum ovale: the effect of calcipotriol scalp solution on scalp psoriasis in psoriasis patients treated with itraconazole or placebo capsules

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

3

Population

adults

2001

MCO 9407 CA

Atrophogenic potential of calcipotriol, betamethasone and mometasone

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone dipropionate

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

1

Population

adults

2001

MCB 0003 INT

Calcipotriol/betamethasone dipropionate once daily in psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol + betamethasone diprop. & calcipotriol

LEO Pharma Product

Daivobet®* & Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

2000

MC 9308 FR

A comparative study of calcipotriol ointment in combination with narrow-band UVB (TL-01) phototherapy and placebo ointment (vehicle of calcipotriol) in combination with narrow-band UVB (TL-01) phototherapy in the treatment of psoriasis vulgaris

NCT01600222

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

2000

MCO 9604 DE

Addition of Daivonex®(calcipotriol) ointment (50 µg/g) to fumaric acid therapy in patients with severe psoriasis vulgaris.

N/A

2012-001507-21

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

2000

MCW 9603 INT

Efficacy and safety of calcipotriol scalp solution II in scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

3

Population

adults

2000

MC 292

A study to investigate the efficacy and safety of calcipotriol soft cream in the treatment of facial psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

2000

MCO 9503 INT

Combination of calcipotriol and methotrexate in psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1999

MC 9301 INT

Calcium metabolism with high-dose calcipotriol

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment & scalp solution

Trial Phase

4

Population

adults

1999

MCO 9508 FR

Investigation on the acceptability of calcipotriol ointment (50 µg/g) under occlusion in patients with finger nail psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

2

Population

adults

1999

MCS 9506 INT

Combined use of calcipotriol solution (50 µg/ml) and Polytar® liquid in scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

3

Population

adults

1999

MCC 9602 INT

Calcipotriol cream in facial psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1998

MC 9304 INT

A comparative study of the efficacy, tolerability and safety of 1: Calcipotriol ointment (50 µg/g) applied twice daily without occlusion for 6 weeks 2: Calcipotriol ointment (50 µg/g) applied once weekly under occlusion for 2 weeks and 3: ointment vehicle applied once weekly under occlusion for 2 weeks for the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1998

MC 392

Efficacy and safety of calcipotriol cream II in the treatment of scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1998

MCO 9701 NL

Calcipotriol ointment and cream and the minimal erythema dose

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment & cream

Trial Phase

1

Population

adults

1998

MCC 9504 CAN

Calcipotriol cream and UVB phototherapy in psoriasis: efficacy and safety of calcipotriol cream plus UVB phototherapy 2 x weekly versus cream vehicle plus UVB phototherapy 3 x weekly in the treatment of psoriasis.

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1998

MCW 9702 UK

(3H)-MC 903 (calcipotriol scalp solution II): A study of percutaneous absorption and excretion following topical administration to healthy male volunteers

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

1

Population

adults

1997

MCC 9401 INT

Long-term treatment of psoriasis with calcipotriol scalp solution and cream: safety and efficacy of calcipotriol scalp solution (50µg/ml) and calcipotriol cream (50µg/g), in the long-term control of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution & cream

Trial Phase

4

Population

adults

1997

MC 9302 INT

A comparative study of the tolerability, safety and efficacy of 1. Calcipotriol cream (50 µg/g) (AM) and concurrent vehicle cream (PM) 2. Calcipotriol cream (50 µg/g) applied twice daily (AM and PM) 3. Calcipotriol cream (50 µg/g) (AM) and concurrent clobetasone 17-butyrate cream (0.5mg/g) (PM) 4. Calcipotriol cream (50 µg/g) (AM) and concurrent betamethasone 17-valerate cream (1 mg/g) (PM)

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1997

CA 9201 UK / GP95

A multicentre, randomised, open, parallel group study of calcipotriol ointment (Dovonex® ointment) and dithranol cream (Dithrocream®) in chronic plaque psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

4

Population

adults

1997

MCS 9406 UK

Calcipotriol solution versus Capasal® in scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

scalp solution

Trial Phase

3

Population

adults

1996

MC 9307 INT

A comparative study of calcipotriol ointment 50 µg/g in combination with UVB phototherapy and UVB phototherapy alone in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1996

MC 9306 INT

LEO Investigation of effect of addition of calcipotriol ointment (50 µg/g) to acitretin therapy in patients with psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1996

MC 492

A study to investigate the efficacy and safety of calcipotriol gel in the treatment of scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

N/A

Formulation

gel

Trial Phase

3

Population

adults

1995

MC 9201 FR

Large-scale efficacy and tolerance of calcipotriol (Daivonex®) ointment in the treatment of psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

4

Population

adults

1995

MC 790

A prospective, non-controlled, open-label trial of the safety and efficacy of calcipotriol ointment in treating children (2-14 yrs) with psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

children

1994

MC 389 FollowUp

A multicentre, prospective, open follow-up of calcipotriol responsive and dithranol unresponsive patients following double-blind treatment

N/A

N/A

Summary

Report

Active Substance

calcipotriol +

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

4

Population

adults

1994

MC 191

Efficacy and safety of calcipotriol ointment in treating children (2 - 14 yrs) with psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

children

1994

MC 390

Comparative study of calcipotriol ointment in combination with UVB phototherapy and calcipotriol ointment alone in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/ Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1994

MC 9202

The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1994

MC 9101 FR

Comparative effects of calcipotriol ointment in combination with cyclosporine A, and placebo ointment (vehicle of calcipotriol) in combination with cyclosporine A in treatment of severe psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1993

CA 9101 UK / GP 92

Comparative effects of calcip-otriol (50 mcg/g)(Dovonex® ointment) and 5% coal tar/2% allantoin/0.5% hydrocortisone cream (Alphosyl® HC cream) in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

4

Population

adults

1993

MC 890

Investigation on the acceptability of calcipotriol solution in patients with psoriasis of the scalp

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

2

Population

adults

1992

MC 490

Comparative effects of calcipotriol (MC 903) solution (50 µg/ml) and placebo solution (vehicle of MC 903 solution) in treatment of scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

scalp solution

Trial Phase

2

Population

adults

1992

MC 1190

Comparative effects of calcipotriol (MC 903) solution (50 µg/ml) and placebo solution (vehicle of MC 903 solution) in treatment of scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

cream

Trial Phase

3

Population

adults

1992

MC 0290 / GP 89

Long term efficacy and safety study of calcipotriol ointment in the treatment of psoriasis vulgaris in general practice

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1992

MC 590

Comparative effects of calcipotriol (MC 903) ointment + PUVA therapy and placebo ointment (vehicle of calcipotriol) + PUVA therapy in the treatment of psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1992

MC 290

Comparative effects of calcipotriol (MC 903) solution (50µg/ml) and betamethasone 17-valerate solution (Betnovate® scalp application) (1mg/ml) in the treatment of scalp psoriasis

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

1991

MC 389

Comparative effects of calcipotriol (MC 903) ointment (B.I.D.) and dithranol cream (‘short contact’) in psoriasis vulgaris

N/A

N/A

Summary

Report

Active Substance

calcipotriol

LEO Pharma Product

Daivonex®/Dovonex®

Formulation

ointment

Trial Phase

3

Population

adults

                   

 

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