Trial Outcomes & Findings for Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds (NCT NCT00640822)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

782 participants

Primary outcome timeframe

Week 8

Results posted on

2025-03-07

Participant Flow

Date of first subject visit was 5 Mar 2008. Date of last subject visit was 18 Jun 2009. Patients came from hospital outpatient clinics or private practice

Forty-one subjects were not randomised. Most we screen failures or did not have the required extent of disease or withdrew before randomization

Participant milestones

Participant milestones
Measure	Calcipotriol Plus Hydrocortisone Ointment Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks	Tacalcitol Ointment Tacalcitol once daily for up to 8 weeks	Calcipotriol Plus Hydrocortisone Ointment Vehicle Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Overall Study STARTED	322	317	102
Overall Study COMPLETED	279	258	77
Overall Study NOT COMPLETED	43	59	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcipotriol Plus Hydrocortisone Ointment n=322 Participants Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks	Tacalcitol Ointment n=317 Participants Tacalcitol once daily for up to 8 weeks	Calcipotriol Plus Hydrocortisone Ointment Vehicle n=102 Participants Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks	Total n=741 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 15.5 • n=5 Participants	49 years STANDARD_DEVIATION 15.5 • n=7 Participants	48.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	48.5 years STANDARD_DEVIATION 15.3 • n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	136 Participants n=7 Participants	41 Participants n=5 Participants	303 Participants n=4 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	181 Participants n=7 Participants	61 Participants n=5 Participants	438 Participants n=4 Participants
Region of Enrollment France	95 participants n=5 Participants	83 participants n=7 Participants	38 participants n=5 Participants	216 participants n=4 Participants
Region of Enrollment Canada	131 participants n=5 Participants	129 participants n=7 Participants	37 participants n=5 Participants	297 participants n=4 Participants
Region of Enrollment United Kingdom	96 participants n=5 Participants	105 participants n=7 Participants	27 participants n=5 Participants	228 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Calcipotriol Plus Hydrocortisone Ointment n=322 Participants Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks	Tacalcitol Ointment n=317 Participants Tacalcitol once daily for up to 8 weeks	Calcipotriol Plus Hydrocortisone Ointment Vehicle n=102 Participants Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8	183 Participants	147 Participants	37 Participants

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Tacalcitol Ointment

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Calcipotriol Plus Hydrocortisone Ointment Vehicle

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Calcipotriol Plus Hydrocortisone Ointment n=321 participants at risk Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks	Tacalcitol Ointment n=316 participants at risk Tacalcitol once daily for up to 8 weeks	Calcipotriol Plus Hydrocortisone Ointment Vehicle n=102 participants at risk Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Cardiac disorders Myocardial infarction	0.31% 1/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Infections and infestations Abscess limb	0.00% 0/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.98% 1/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Injury, poisoning and procedural complications Lower limb fracture	0.31% 1/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.31% 1/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Nervous system disorders Epilepsy	0.31% 1/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.31% 1/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.63% 2/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.98% 1/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Psychiatric disorders Disorientation	0.00% 0/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.98% 1/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Surgical and medical procedures Hip arthroplasty	0.00% 0/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.32% 1/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.
Vascular disorders Thrombosis	0.00% 0/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.00% 0/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	0.98% 1/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.

Other adverse events

Other adverse events
Measure	Calcipotriol Plus Hydrocortisone Ointment n=321 participants at risk Calcipotriol Plus Hydrocortisone Ointment once daily for up to 8 weeks	Tacalcitol Ointment n=316 participants at risk Tacalcitol once daily for up to 8 weeks	Calcipotriol Plus Hydrocortisone Ointment Vehicle n=102 participants at risk Calcipotriol Plus Hydrocortisone Ointment vehicle once daily for up to 8 weeks
Skin and subcutaneous tissue disorders Erythema	4.0% 13/321 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	9.5% 30/316 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.	2.0% 2/102 The safety analysis set consists of all randomised subjects who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events was available. Two subjects withdrew within the first week of the study and did not apply any study medication so they were excluded from the safety analysis set.

Additional Information

Torsten Skov

LeoPharma

Phone: +4520736294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Company acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Publication restrictions are in place

Restriction type: OTHER