Trial Outcomes & Findings for Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris (NCT NCT00670241)

NCT ID: NCT00670241

Last Updated: 2025-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2025-03-10

Participant Flow

Participant milestones

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment Tacalcitol Ointment for up to 8 weeks	Gel Vehicle Gel Vehicle for up to 8 weeks
Overall Study STARTED	183	184	91
Overall Study COMPLETED	171	163	64
Overall Study NOT COMPLETED	12	21	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris

Baseline characteristics by cohort

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=183 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 Participants Gel Vehicle for up to 8 weeks	Total n=458 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	148 Participants n=5 Participants	155 Participants n=7 Participants	74 Participants n=5 Participants	377 Participants n=4 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	29 Participants n=7 Participants	17 Participants n=5 Participants	81 Participants n=4 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 14.3 • n=5 Participants	51.7 years STANDARD_DEVIATION 13.4 • n=7 Participants	52.8 years STANDARD_DEVIATION 14.9 • n=5 Participants	51.6 years STANDARD_DEVIATION 14.0 • n=4 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	69 Participants n=7 Participants	38 Participants n=5 Participants	173 Participants n=4 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	115 Participants n=7 Participants	53 Participants n=5 Participants	285 Participants n=4 Participants
Region of Enrollment Canada	183 participants n=5 Participants	184 participants n=7 Participants	91 participants n=5 Participants	458 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=183 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 Participants Gel Vehicle for up to 8 weeks
Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8	73 Participants	33 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 4

Outcome measures

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=183 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 Participants Gel Vehicle for up to 8 weeks
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4	34 participants	12 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Week 4 and 8

PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).

Outcome measures

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=183 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 Participants Gel Vehicle for up to 8 weeks
The Percentage Change in PASI From Baseline to Week 8	-57.0 Percent change in PASI score	-41.9 Percent change in PASI score	-17.9 Percent change in PASI score

SECONDARY outcome

Timeframe: Week 8-16

Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit

Outcome measures

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=67 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=31 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=5 Participants Gel Vehicle for up to 8 weeks
Subjects With Relapse During the Study	28 participants	7 participants	3 participants

SECONDARY outcome

Timeframe: Week 8-16

Outcome measures

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=67 Participants Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=31 Participants Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=5 Participants Gel Vehicle for up to 8 weeks
Subjects With Rebound During the Study	0 participants	0 participants	0 participants

Adverse Events

Calcipotriol Plus Betamethasone Dipropionate Gel

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Tacalcitol Ointment

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Gel Vehicle

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=182 participants at risk Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 participants at risk Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 participants at risk Gel Vehicle for up to 8 weeks
Cardiac disorders Arrhythmia	0.00% 0/182	0.54% 1/184	0.00% 0/91
Cardiac disorders Myocardial infarction	0.00% 0/182	0.00% 0/184	1.1% 1/91
Infections and infestations Gastroenteritis	0.00% 0/182	0.54% 1/184	0.00% 0/91
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/182	0.54% 1/184	0.00% 0/91
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/182	0.54% 1/184	0.00% 0/91

Other adverse events

Measure	Calcipotriol Plus Betamethasone Dipropionate Gel n=182 participants at risk Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks	Tacalcitol Ointment n=184 participants at risk Tacalcitol Ointment for up to 8 weeks	Gel Vehicle n=91 participants at risk Gel Vehicle for up to 8 weeks
Infections and infestations Nasopharyngitis	6.0% 11/182	3.3% 6/184	1.1% 1/91
Infections and infestations Upper respiratory tract infection	4.4% 8/182	5.4% 10/184	2.2% 2/91
Skin and subcutaneous tissue disorders Pruritus	3.3% 6/182	7.1% 13/184	7.7% 7/91

Additional Information

Anders Rhod Larsen, Scientific Advisor

LEO Pharma

Phone: +4572262990

Email: anders.larsen@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place